Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

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

• 2025-10-14Open, ClassifiedPackage design/selection

  BioPro Femoral Head Product ID/Description 14089 HEAD FEMORAL 28 SH LT 14090 HEAD FEMORAL 28 MD LT 14091 HEAD FEMORAL 28 LG LT 14094 HEAD FEMORAL 32 SH LT 14095 HEAD FEMORAL 32 MD LT 14096 HEAD FEMORAL 32 LG LT

  Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.

• 2025-09-26Open, ClassifiedUnder Investigation by firm

  1. EXETER V40 STEM 44MM NO 2, Model/Catalog Number: 0580-1-442; 2. EXETER V40 STEM 37.5MM NO 0, Model/Catalog Number: 0580-1-352;

  a potential product mix where the package labeled as Catalog Number 0580-1-442, lot A00976, may contain Catalog Number 0580-1-352, lot G8754849, and vice versa. Patient labels may also be impacted.

• 2025-08-25Open, ClassifiedUnder Investigation by firm

  ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS BOWED CANAL FILLING STEMS. Canal filling stem implants.

  Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.

• 2025-08-25Open, ClassifiedUnder Investigation by firm

  ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS SEGMENTAL STEM CANAL FILLING STRAIGHT SLOTTED SPLINED 2/3 PLASMA. Canal filling stem implants.

  Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.

• 2025-08-25Open, ClassifiedUnder Investigation by firm

  ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS STEM EXTENSION, STRAIGHT, SPLINED, SLOTTED. Canal filling stem implants.

  Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.

• 2025-05-29Open, ClassifiedPackaging change control

  Ethos Collar Stem, Cemented, Fluted, 100MM, 1 EACH. Model Numbers: HC-09100-03M, HC-10100-03M, HC-11120-03M, HC-13120-03M, HC-15120-03M, HC-17120-03M. Component of ELEOS SEGMENTAL LIMB SALVAGE SYSTEM

  Potential for breach of Tyvek seals.

• 2025-05-23Open, ClassifiedLabeling Change Control

  ELEOS COLLAR STEM, CEMENTED, FLUTED, 13MM X 120MM. Model Number: HC-13120-03M. Component of Limb Salvage System with BioGrip.

  Mislabeling of 13mm Modular Segmental Stem package (HC-13120-03M) which included an implant that was 15mm in diameter (HC-15120-03M) instead of being 13mm as stated on the package. The corresponding 15mm cemented stems were mislabeled as size 13mm cemented stems.

• 2025-05-23Open, ClassifiedLabeling Change Control

  ELEOS COLLAR STEM, CEMENTED, FLUTED, 15MM X 120MM. Model Number: HC-15120-03M. Component of Limb Salvage System with BioGrip.

  Mislabeling of 13mm Modular Segmental Stem package (HC-13120-03M) which included an implant that was 15mm in diameter (HC-15120-03M) instead of being 13mm as stated on the package. The corresponding 15mm cemented stems were mislabeled as size 13mm cemented stems.

• 2024-08-26Open, ClassifiedProcess control

  Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific); Catalog Number: C-MM100434-00;

  A patient specific, custom-made device was supplied for a surgical procedure that did not match the design proposal.

• 2024-07-30Open, ClassifiedUnder Investigation by firm

  CPT Hip Joint Metal/Polymer Semi-Constrained Cemented Prosthesis, used in Hip Arthroplasty; Item Numbers 00811400000 00811400010 00811400100 00811400110 00811400200 00811400210 00811400218 00811400230 00811400300 00811400310 00811400318 00811400330 00811400400 00811400410 00811400420 00811400423 00811400426 00811400430 00811400500 00811400510 00811400530 00811401218 00811401318 00811404000 00811405000

  Affected product has an increased risk of postoperative perisprosthetic femoral fracture (PFF). The IFU is being updated to reflect the risk of PFF.