Taperloc Complete Primary Femoral 51-103200Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00880304498365), received between Mar 16, 2023 and May 20, 2025 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE IMPLANT BROKE THROUGH THE PACKAGING WHICH COMPROMISED THE STERILE PLASTIC CONTAINER. THERE WAS NO PATIENT INVOLVEMENT. THERE IS NO FURTHER INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22052107 ↗
• MalfunctionDec 30, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT THE PRODUCT PACKAGING WAS DAMAGED. 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 21038225 ↗
• MalfunctionDec 30, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT THE PRODUCT PACKAGING WAS DAMAGED. 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 21038173 ↗
• MalfunctionMay 21, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE STERILE PACKAGING WAS DAMAGED. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19358878 ↗
• InjuryMar 18, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED DURING THE REVISION, THE STEM WOULD NOT DISENGAGE FROM THE HEAD. THE STEM AND HEAD WERE REMOVED AND NEW ONES WERE USED TO COMPLETE THE PROCEDURE. THERE WAS NO HARM OR HEALTH IMPACT TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18921896 ↗
• MalfunctionApr 27, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16824728 ↗
• MalfunctionMar 16, 2023Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT THERE IS PLASTIC-LIKE DUST AND DEBRIS INSIDE 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 16555120 ↗