Taperloc Complete Primary Femoral 51-100070Recalls & reported problems
Biomet Orthopedics, LLC · Class 2 · Implant
All models of Taperloc Complete Primary Femoral (40)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 15
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00880304489653), received between Mar 24, 2020 and Sep 25, 2026 — classified as 2 injuries, 13 malfunctions.
The most frequently reported specific device problem is “Packaging Problem” (4 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Packaging Problem4
- Tear, Rip or Hole in Device Packaging4
- Device Contaminated During Manufacture or Shipping2
- Inadequacy of Device Shape and/or Size2
- Delivered as Unsterile Product1
- Failure to Osseointegrate1
- Flaked1
- Implant subsidence1
Patient problems
- No Clinical Signs, Symptoms or Conditions12
- Inadequate Osseointegration1
- Joint Dislocation1
- No Known Impact Or Consequence To Patient1
- Pain1
Recent adverse event reports
The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Tear, Rip or Hole in Device Packaging
It was reported that during inspection of circulated stock inventory, a sterile packaging pouch was found damaged. There was no patient involvement. Attempts have been made and no further information has been provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50898605 ↗MalfunctionOct 28, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
NO ADDITIONAL INFORMATION AVAILABLE FOR THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23406381 ↗InjuryOct 24, 2025Inadequacy of Device Shape and/or Size; Implant subsidence; Inadequacy of Device Shape and/or Size; Implant subsidence
MalfunctionSep 30, 2025Packaging Problem; Packaging Problem
NO ADDITIONAL EVENT INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23181342 ↗MalfunctionJul 14, 2025Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging; Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT WHEN THE IMPLANT WAS OPENED FOR SURGERY, THE STEM WAS STICKING THROUGH THE INNER PLASTIC PACKAGING. THE OUTSIDE PACKAGE WAS FINE. ANOTHER STEM WAS USED. THERE WAS NO KNOWN IMPACT OR CONSEQUENCES TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22493125 ↗MalfunctionMar 6, 2025Packaging Problem; Packaging Problem
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21539280 ↗MalfunctionFeb 5, 2025Packaging Problem; Packaging Problem
IT WAS REPORTED THAT THE STERILE PACKAGING TO THE STEM WAS FOUND UNSTERILE. THERE WAS NO PATIENT INVOLVEMENT. IT WAS REPORTED THAT NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21314405 ↗MalfunctionJan 30, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT THE INNER PACKAGING WAS DAMAGED, BOTH THE BLISTER AND POUCH. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21272804 ↗MalfunctionSep 17, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20235769 ↗MalfunctionJul 24, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19818347 ↗MalfunctionJul 6, 2022Packaging Problem; Packaging Problem
IT WAS REPORTED THAT THE STERILE PACKAGE WAS DAMAGED. THE TIP OF THE IMPLANT WAS PROTRUDING OUT OF THE STERILE PACKAGE PRIOR TO BEING OPENED. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14934647 ↗MalfunctionDec 9, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
NO ADDITIONAL INFORMATION ON THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12967816 ↗InjuryDec 1, 2021Failure to Osseointegrate; Failure to Osseointegrate
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Inadequate Osseointegration; Pain
MAUDE report 12913767 ↗MalfunctionSep 13, 2021Flaked; Flaked
IT WAS REPORTED THAT DURING A HIP PROCEDURE, THE POROUS COATING PEELED OFF THE STEM ON THE PROXIMAL LATERAL SHOULDER. THE STEM WAS ABLE TO BE IMPLANTED AS INTENDED WITH NO REPORTED HARM OR INJURY TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12461201 ↗MalfunctionMar 24, 2020Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED, WHILE INVESTIGATING CIRCULATED ITEMS, MANY PACKAGES HAD DEBRIS IN THE STERILE PACKAGING. NO PATIENTS WERE INVOLVED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9872365 ↗
Other Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate devices
- Novation 130-32-51Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls156 reports
- Novation 130-36-53Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls79 reports
- CORAIL 3L92511Depuy (Ireland) · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate158 reports
- Acumatch A Series 138-36-29Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate3 recalls1 report
- Novation 136-32-51Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls43 reports
- Novation 130-32-53Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls33 reports
- Novation 132-32-51Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls26 reports
- Novation 136-36-53Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls22 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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