Prosthesis, Hip, Femoral Component, Cemented, Metal

Reports per year

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Recent recalls

• 2025-08-11Open, ClassifiedUnder Investigation by firm

  Prosthesis Head B, 28 mm, 7 mm neck length. Item Number: 198-828/04.

  Inconsistent size terminology and color coding used on labeling

• 2025-08-11Open, ClassifiedUnder Investigation by firm

  Plastic Trial Head Brown, 7 mm neck length. Item Number: 175-928/15.

  Inconsistent size terminology and color coding used on labeling

• 2024-03-14Open, ClassifiedUnder Investigation by firm

  SPII Model Lubinus, Hip Prosthesis Stem Standard Neck, cemented

  Due to two complaints, has come to our attention that additional guidance is required on the correct interpretation of the carton label Size and Type columns to avoid misinterpretation during surgery.

• 2024-03-14Open, ClassifiedUnder Investigation by firm

  SPII Model Lubinus, Hip Prosthesis Stem XL Neck, cemented

  Due to two complaints, has come to our attention that additional guidance is required on the correct interpretation of the carton label Size and Type columns to avoid misinterpretation during surgery.

• 2024-03-14Open, ClassifiedUnder Investigation by firm

  SPII Model Lubinus, Long Stem Prosthesis Standard Neck, cemented

  Due to two complaints, has come to our attention that additional guidance is required on the correct interpretation of the carton label Size and Type columns to avoid misinterpretation during surgery.

• 2024-03-14Open, ClassifiedUnder Investigation by firm

  SPII Model Lubinus, Long Stem Prosthesis XL Neck, cemented

  Due to two complaints, has come to our attention that additional guidance is required on the correct interpretation of the carton label Size and Type columns to avoid misinterpretation during surgery.

• 2014-08-26TerminatedPackage design/selection

  Moore & Thompson Hip Stems: FNSTRD HIP 38HDX127ST FNSTRD HIP 40HDX127ST FNSTRD HIP 41HDX127ST FNSTRD HIP 42HDX127ST FNSTRD HIP 43HDX127ST FNSTRD HIP 44HDX127ST FNSTRD HIP 45HDX140ST FNSTRD HIP 46HDX140ST FNSTRD HIP 47HDX140ST FNSTRD HIP 48HDX140ST FNSTRD HIP 49HDX140ST FNSTRD HIP 50HDX152ST FNSTRD HIP 51HDX152ST FNSTRD HIP 52HDX152ST FNSTRD HIP 53HDX152ST FNSTRD HIP 54HDX152ST FNSTRD HIP 55HDX152ST FNSTRD HIP 57HDX152ST FNSTRD HIP 60HDX152ST FNSTRD HIP 63HDX152ST FNSTRD HIP 38HDX140ST FNSTRD HIP 40HDX140ST FNSTRD HIP 41HDX140ST FNSTRD HIP 42HDX140ST FNSTRD HIP 43HDX140ST FNSTRD HIP 44HDX140ST FNSTRD HIP 45HDX152ST FNSTRD HIP 46HDX152ST FNSTRD HIP 47HDX152ST FNSTRD HIP 48HDX152ST FNSTRD HIP 49HDX152ST FNSTRD HIP 50HDX152ST FNSTRD HIP 51HDX152ST HIP PROS 38HDX105ST HIP PROS 40HDX105ST HIP PROS 41HDX105ST HIP PROS 42HDX105ST HIP PROS 43HDX105ST HIP PROS 44HDX105ST HIP PROS 45HDX105ST HIP PROS 46HDX105ST HIP PROS 47HDX105ST HIP PROS 48HDX105ST HIP PROS 49HDX105ST HIP PROS 50HDX105ST HIP PROS 51HDX105ST HIP PROS 52HDX105ST HIP PROS 53HDX105ST HIP PROS 54HDX105ST HIP PROS 55HDX105ST HIP PROS 57HDX105ST HIP PROS 60HDX105ST HIP PROS 63HDX105ST FNSTRD HIP 38HDX165ST FNSTRD HIP 40DX165ST FNSTRD HIP 41HDX165ST FNSTRD HIP 42HDX165ST FNSTRD HIP 43HDX165ST FNSTRD HIP 44HDX165ST FNSTRD HIP 45HDX165ST FNSTRD HIP 46HDX165ST FNSTRD HIP 47HDX165ST FNSTRD HIP 48HDX165ST FNSTRD HIP 49HDX165ST FNSTRD HIP 50HDX191ST FNSTRD HIP 51HDX191ST FNSTRD HIP 52HDX191ST FNSTRD HIP 53HDX191ST FNSTRD HIP 54HDX191ST FNSTRD HIP 55HDX191ST FNSTRD HIP 57HDX191ST FNSTRD HIP 60HDX191ST FNSTRD HIP 63HDX191ST FNSTRD HIP 38HDX165ST FNSTRD HIP 41HDX165ST FNSTRD HIP 43HDX165ST FNSTRD HIP 44HDX165ST FNSTRD HIP 46HDX165ST FNSTRD HIP 48HDX165ST FNSTRD HIP 49HDX165ST FNSTRD HIP 51HDX165ST HIP PROS 38HDX127ST HIP PROS 40HDX127ST HIP PROS 41HDX127ST HIP PROS 42HDX127ST HIP PROS 43HDX127ST HIP PROS 44HDX127ST HIP PROS 45HDX140ST HIP PROS 46HDX140ST HIP PROS 47HDX140ST HIP PROS 48HDX140ST HIP PROS 49HDX140ST HIP PROS 50HDX152ST HIP PROS 51HDX152ST HIP PROS 52HDX152ST HIP PROS 53HDX152ST HIP PROS 54HDX152ST HIP PROS 55HDX152ST HIP PROS 57HDX152ST HIP PROS 60HDX152ST HIP PROS 63HDX152ST HIP PROS 38HDX165ST HIP PROS 40HDX165ST HIP PROS 41HDX165ST HIP PROS 42HDX165ST HIP PROS 43HDX165ST HIP PROS 44HDX165ST HIP PROS 45HDX165ST HIP PROS 46HDX165ST HIP PROS 47HDX165ST HIP PROS 48HDX165ST HIP PROS 49HDX165ST HIP PROS 50HDX191ST HIP PROS 51HDX191ST HIP PROS 52HDX191ST HIP PROS 53HDX191ST HIP PROS 54HDX191ST HIP PROS 55HDX191ST HIP PROS 57HDX191ST HIP PROS 60HDX191ST HIP PROS 63HDX191ST

  Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. Specifically, multiple test samples from each of the six configurations failed simulated distribution and shipping testing when the devices either breached inner or outer package trays or seal integrity was lost.

• 2014-08-13TerminatedPackaging process control

  Moore Hip Prosthesis Long Fenestrated Stem 38 mm (1-1/2 Inch) Head Diameter 203 mm Length. Product Usage: The Moore Hip Prosthesis is a femoral him stem that can be used where there is roentgenogrpahic evidence of a satisfactory actabulum and sufficient bone in the femoral neck to seat the prosthesis with or without bone cement.

  Zimmer is initiating a voluntary recall of 20 production lots of Moore Hip Prosthesis Long Fenestrated Stems due to packaging design verification test failures. Specifically, 9 of 16 test samples failed simulated distribution and shipping testing when the Moore hip stem breached either the inner or outer package tray. Zimmer has not received any complaints of damaged package trays for these 20 lot

• 2014-02-20TerminatedPackaging

  MOORE HIP PROS LONG FENES, MOORE HIP PROS NRW STR FE, MOORE HIP PROS STR FENEST, THOMPSON HIP PROSTHESIS 3, 4, 5 and 6.

  Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations.

• 2014-02-20TerminatedPackaging

  MOORE HIP PROS LONG FENES, MOORE HIP PROS NRW STR FE, MOORE HIP PROS STR FENEST, THOMPSON HIP PROSTHESIS sizes 3, 4, 5, and 6, and Mod Austin Moore Fem Stem

  Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations.