Taperloc Complete Primary Femoral 51-101080Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00880304489721), received between Jan 7, 2020 and Aug 26, 2026 — classified as 3 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (6 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.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2026Tear, Rip or Hole in Device Packaging

  It was reported that damaged sterile packaging was identified during stock inspection. During inspection of circulated items, the sterile packaging pouch was found damaged. There was no patient involvement. It was reported no further information available.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50452584 ↗
• MalfunctionMay 15, 2026Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE STERILE PACKAGING WAS FOUND DAMAGED DURING STOCK INSPECTION. BLISTER AND POUCH DAMAGED. THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25185999 ↗
• MalfunctionOct 24, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE PRODUCT PUNCTURED THE STERILE PACKAGING. THERE WAS NO PATIENT INVOLVEMENT. IT WAS REPORTED THAT NO FURTHER INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23383631 ↗
• MalfunctionSep 4, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE IMPLANT SAT 3-4MM HIGHER THAN THE BROACH. THE SURGEON EXPRESSED THAT THIS WAS NOTICED WITH IMPLANTS THAT COME FROM OLDER BOXES. NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22967481 ↗
• MalfunctionSep 2, 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 22937231 ↗
• MalfunctionJun 18, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  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 22284076 ↗
• InjuryAug 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL HIP PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY 1 YEAR LATER DUE TO LEG LENGTH DISCREPANCY. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Unequal Limb Length

  MAUDE report 20053819 ↗
• InjuryJun 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

  Patient problems: Bursitis; Pain

  MAUDE report 19621019 ↗
• InjuryJul 18, 2023Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 17342393 ↗
• MalfunctionMar 7, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DURING WAREHOUSE INSPECTION, DEBRIS WAS FOUND IN THE STERILE PACKAGING. THERE WAS NO 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 13678826 ↗
• MalfunctionFeb 1, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED IMPLANT WAS NOT IMPLANTED INTO PATIENT. TAPERLOC STEM WAS OPENED TO THE FIELD. FIRST STERILE PACK WAS INTACT, BUT THE SECOND STERILE PACK WAS RIPPED. STEM WAS NOT IMPLANTED INTO THE PATIENT; IT WAS PASSED OFF THE FIELD AND A NEW ONE WAS OPENED TO REPLACE IT. 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 11258562 ↗
• MalfunctionJan 7, 2020Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  UPON INVESTIGATION, IT HAS BEEN DETERMINED THAT THE DEBRIS IN THE STERILE PACKAGING MEETS THE ACCEPTABLE CRITERIA AND PRODUCT IS CONFORMING TO SPECIFICATIONS. EVENT IS NO LONGER CONSIDERED REPORTABLE, AND INITIAL REPORT SHOULD BE VOIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9558501 ↗