Device, Fixation, Proximal Femoral, Implant
FDA adverse event reports and recall history for device, fixation, proximal femoral, implant (product code JDO), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 286
- Deaths
- 0
- Injuries
- 180
- Malfunctions
- 75
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
- 2020-01-29TerminatedUnder Investigation by firm
THP Hip Plating System, Item Nos. 14-451070 14-451075 14-451080 14-451085 14-451090 14-451095 14-451100 14-451105 14-451110 14-451115 14-451120 14-451125 14-451130 . The product is a metallic bone fixation system.
Potential increase in fracture rate was detected during internal testing, in addition to potential discoloration inside the inner pouch of the packaging.
- 2016-07-19TerminatedDevice Design
TSP Hip Fracture Plating System device, fixation, proximal femoral, implant The Biomet Hip Fracture Plating Systems are indicated for use in the open reduction and internal fixation of a wide variety of fractures of the proximal femur: intracapsular fractures and intertrochanteric fractures. Fracture plates with six or more femoral shaft fixation screw holes are also indicated for subtrochanteric fractures as well as proximal femoral osteotomies
The screw may fracture at the junction of the shaft and the head during implantation. The patient may retain a foreign body if the fractured screw cannot be removed. Soft tissue irritation will not occur as the retained portion of the screw is below the surface of the plate. A delay in surgery less than 30 minutes may occur.
- 2014-02-20TerminatedPackaging
Item codes starting with 001930 LAG SCR 12.7D X 55MM SHOR up to 155 MM, LAG SCR 12.7D X 55 MM SHO up to 100MM, LAG SCR 12.7D X 55MM STAN up to 155 MM, LAG SCR 15.8D X 55MM LARG up to 155 MM
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.
- TerminatedLabeling design
Custom Made Implant System with Minimum Invasive Grower (MIG) component
From March 2007 to October 2014, product did not contain updated instructions for use (IFU) to clarify the function of locking mechanism and warnings related to the locking screw.
- TerminatedProcess design
HipLOC Hip Fracture Fixation System- Hiploc System 130 Plate 38 mm Barrel 4 Hole Plate Item Number: 2110-130-004 Product Usage: The HipLOC Compression Hip Screw may be used primarily for fixation of bone fractures. Specific indications include open reduction and internal fixation of a wide variety of fractures of the proximal femur: intracapsular fractures, intertrochanteric fractures and subtrochanteric fractures
HipLOC System Plate Barrel due to an undersized bore on the HipLOC plate barrel, can result in the lag screw not fitting through the barrel
- TerminatedProcess design
HipLOC Hip Fracture Fixation System-Hiploc System 135 Plate 38 mm Barrel 3 Hole Plate Item Number: 2110-135-003 Product Usage: The HipLOC Compression Hip Screw may be used primarily for fixation of bone fractures. Specific indications include open reduction and internal fixation of a wide variety of fractures of the proximal femur: intracapsular fractures, intertrochanteric fractures and subtrochanteric fractures
HipLOC System Plate Barrel due to an undersized bore on the HipLOC plate barrel, can result in the lag screw not fitting through the barrel
- TerminatedProcess design
HipLOC Hip Fracture Fixation System-Hiploc System 135 Plate 38 mm Barrel 4 Hole Plate Item Number: 2110-135-004 Product Usage: The HipLOC Compression Hip Screw may be used primarily for fixation of bone fractures. Specific indications include open reduction and internal fixation of a wide variety of fractures of the proximal femur: intracapsular fractures, intertrochanteric fractures and subtrochanteric fractures
HipLOC System Plate Barrel due to an undersized bore on the HipLOC plate barrel, can result in the lag screw not fitting through the barrel
- TerminatedProcess design
HipLOC Hip Fracture Fixation System-Hiploc System 140 Plate 38 mm Barrel 4 Hole Plate Item Number: 2110-140-004 Product Usage: The HipLOC Compression Hip Screw may be used primarily for fixation of bone fractures. Specific indications include open reduction and internal fixation of a wide variety of fractures of the proximal femur: intracapsular fractures, intertrochanteric fractures and subtrochanteric fractures
HipLOC System Plate Barrel due to an undersized bore on the HipLOC plate barrel, can result in the lag screw not fitting through the barrel
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