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Taperloc Complete Micro Primary Femoral 51-107140Recalls & reported problems

Biomet Orthopedics, LLC · Class 3 · Implant

All models of Taperloc Complete Micro Primary Femoral (35)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Quick summary

This Biomet Taperloc hip stem is a metal implant used in hip replacement surgery. The 35 reports mostly describe packaging problems rather than device breakage — torn or punctured sterile pouches, shipping and manufacturing handling issues, and a few products arriving unsterile or contaminated, generally spotted during inspection of stock with no patient involved. Two reports describe injuries and no deaths. There are no recalls naming this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
36
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 00880304513518), received between Apr 2, 2020 and Sep 15, 2026 — classified as 2 injuries, 34 malfunctions.

The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (13 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

Nov 2023: 1 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 1 reportsAug 2024: 1 reportsSep 2024: 0 reportsOct 2024: 1 reportsNov 2024: 1 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 3 reportsApr 2025: 1 reportsMay 2025: 1 reportsJun 2025: 1 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 1 reportsNov 2025: 1 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 2 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 1 reportsJul 2026: 0 reportsAug 2026: 2 reportsSep 2026: 2 reportsOct 2026: 0 reports2024202520263
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Tear, Rip or Hole in Device Packaging13
  • Manufacturing, Packaging or Shipping Problem9
  • Packaging Problem5
  • Device Contaminated During Manufacture or Shipping4
  • Delivered as Unsterile Product2
  • Difficult to Insert1
  • Insufficient Device Problem Information1
  • Migration1

Patient problems

  • No Clinical Signs, Symptoms or Conditions29
  • No Known Impact Or Consequence To Patient2
  • No Patient Involvement2
  • Failure of Implant1
  • Insufficient Information1
  • No Information1
  • Pain1

Recent adverse event reports

The 25 most recent of 36 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 15, 2026Tear, Rip or Hole in Device Packaging

    It was reported that damaged sterile packaging pouch was identified during inspection of circulated stock items. No additional information available for the reported event.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50772948 ↗
  • MalfunctionSep 2, 2026Tear, Rip or Hole in Device Packaging

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50571100 ↗
  • MalfunctionAug 31, 2026Tear, Rip or Hole in Device Packaging

    It was reported that damaged sterile packaging was identified during inspection of circulated stock items. No patient involvement. No additional information available for the reported event.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50529811 ↗
  • MalfunctionAug 13, 2026Tear, Rip or Hole in Device Packaging

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50238254 ↗
  • MalfunctionJun 15, 2026Tear, Rip or Hole in Device Packaging

    No further event information is available at the time of this report.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25503508 ↗
  • MalfunctionFeb 17, 2026Tear, Rip or Hole in Device Packaging

    IT WAS REPORTED THAT DURING INSPECTION OF CIRCULATING STOCK, A STERILE PACKAGE 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 24370193 ↗
  • MalfunctionFeb 17, 2026Tear, Rip or Hole in Device Packaging

    IT WAS REPORTED THAT DURING INSPECTION OF CIRCULATING STOCK, A STERILE PACKAGE 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 24370192 ↗
  • MalfunctionNov 6, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

    NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23487237 ↗
  • 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 23404800 ↗
  • MalfunctionJun 20, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

    IT WAS REPORTED THAT WHILE INSPECTING STOCK, THE STERILE PACKAGE WAS FOUND DAMAGED. THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22298610 ↗
  • MalfunctionMay 1, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

    IT WAS REPORTED THAT THE WHILE INSPECTING THE PRODUCT, THE PACKAGING WAS FOUND DAMAGED. THERE WAS NO PATIENT INVOLVEMENT. THERE IS NO FURTHER INFORMATION AVAILABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21941314 ↗
  • MalfunctionApr 29, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

    IT WAS REPORTED THAT WHILE INSPECTING CIRCULATED ITEMS, IT WAS FOUND THAT THE STERILE PACKAGING WAS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT, AND IT WAS REPORTED NO FURTHER INFORMATION IS AVAILABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21928315 ↗
  • MalfunctionMar 24, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

    NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21676527 ↗
  • MalfunctionMar 12, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

    UPON RECEIVING ADDITIONAL INFORMATION OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE AS THIS PRODUCT STERILITY WAS NOT BREACHED. THE INITIAL REPORT SHOULD BE VOIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21584850 ↗
  • MalfunctionMar 10, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

    NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21569206 ↗
  • InjuryNov 27, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

    THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.

    Patient problems: Insufficient Information

    MAUDE report 20795199 ↗
  • MalfunctionOct 24, 2024Packaging Problem; Packaging Problem

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20527018 ↗
  • MalfunctionAug 23, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

    IT WAS REPORTED THAT DURING INSPECTION OF CIRCULATED STOCK, THE STERILE PACKAGE 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 20048634 ↗
  • MalfunctionJul 8, 2024Difficult to Insert; Difficult to Insert

    NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19687847 ↗
  • MalfunctionNov 14, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

    IT WAS REPORTED BY THE DISTRIBUTORSHIP THAT DURING INCOMING INSPECTION, THERE WAS DAMAGE TO THE STERILE PACKAGING. THERE WAS NO PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18129398 ↗
  • MalfunctionAug 25, 2023Packaging Problem; Packaging Problem

    NO ADDITIONAL EVEN INFORMATIN TO REPORT AT THIS TIME.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17622920 ↗
  • MalfunctionFeb 16, 2023Packaging Problem; Packaging Problem

    IT WAS REPORTED WHILE INSPECTING THE CIRCULATING ITEMS IN STOCK, THE STERILE PACKAGING WAS FOUND TO BE DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16392750 ↗
  • MalfunctionOct 31, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

    IT WAS REPORTED THAT DURING A HIP PROCEDURE, IT WAS NOTICED THAT THE IMPLANT WAS STICKING OUT OF THE STERILE PACKAGING. THERE WAS NO DIRECT PATIENT INVOLVEMENT. 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 15699097 ↗
  • MalfunctionAug 15, 2022Packaging Problem; Packaging Problem

    IT WAS REPORTED THAT THE STERILE PACKAGE WAS NOTED AS DAMAGED DURING INCOMING INSPECTION. NO PATIENT OR PROCEDURE INVOLVEMENT AND NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15229527 ↗
  • InjuryJul 25, 2022Migration; Migration

    IT WAS REPORTED PATIENT UNDERWENT A LEFT HIP REVISION APPROXIMATELY 9 MONTHS POST IMPLANTATION DUE TO PROGRESSIVE PAIN. DURING THE SURGERY, IT WAS NOTED THAT THE STEM APPEARS TO HAVE POTTED DUE TO EXCESSIVE PPS SPRAY AT THE REDUCED DISTAL PORTION OF THE STEM. THE STEM AND HEAD WERE REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Patient problems: Failure of Implant; Pain

    MAUDE report 15091878 ↗

Other Prosthesis, hip, semi-constrained (metal cemented acetabular component) devices

All Prosthesis, hip, semi-constrained (metal cemented acetabular component) devices →

Sources and updates

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