Taperloc Complete Primary Femoral 51-103130Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00880304489677), received between Mar 24, 2020 and Feb 23, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (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.

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.

• MalfunctionFeb 23, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DAMAGED STERILE PACKAGING WITH URETHANE IDENTIFIED DURING INSPECTION OF CIRCULATED STOCK ITEMS. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION AVAILABLE FOR THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24415748 ↗
• MalfunctionDec 9, 2025Tear, Rip or Hole in Device Packaging; Tear, 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 23759568 ↗
• MalfunctionDec 8, 2025Packaging Problem; Packaging Problem

  A PACKAGING ISSUE WAS IDENTIFIED INVOLVING TAPERLOC STEMS. THE INNER VACUUM PACKAGING WAS OBSERVED TO HAVE LOST VACUUM, ALLOWING THE STEM TO CONTACT AND RUB AGAINST THE INNER PLASTIC. SURGEONS REPORTED CONCERN THAT STERILITY MAY BE COMPROMISED UNDER THESE CONDITIONS AND ELECTED NOT TO USE THE AFFECTED UNITS. NO PATIENTS WERE INVOLVED, AND NO PROCEDURES WERE IMPACTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23743646 ↗
• 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 23404882 ↗
• MalfunctionMay 9, 2025Packaging Problem; Packaging Problem

  IT WAS REPORTED DURING INSPECTION THAT THE STERILE PACKAGING OF THE CIRCULATED ITEMS WAS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21994584 ↗
• MalfunctionApr 18, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT WHILE INSPECTING THE PRODUCT, THE STERILE PACKAGING WAS FOUND DAMAGED. 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 21864253 ↗
• MalfunctionMar 24, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT WHEN INSPECTING THE PRODUCT, IT WAS FOUND WITH INNER PACKAGING DAMAGE. THERE WAS NO PATIENT INVOLVEMENT. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21676539 ↗
• MalfunctionSep 26, 2024Packaging Problem; Packaging Problem

  NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20311186 ↗
• MalfunctionFeb 8, 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 16328802 ↗
• MalfunctionMar 3, 2022Device Contaminated During Manufacture or Shipping; Packaging Problem; Device Contaminated During Manufacture or Shipping; Packaging Problem

  IT WAS REPORTED THAT THE INSIDE STERILE WRAP APPEARED TO CONTAIN SHAVINGS FROM IMPLANT RUBBING ON WRAP PLASTIC. UPON INSPECTION OF THE PACKAGING, THE VACUUM SEAL HAS BEEN BROKEN, THEREFORE COMPROMISING STERILITY. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13658781 ↗
• MalfunctionFeb 15, 2022Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping; Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE OUTSIDE PLASTIC AND BOX OF THE IMPLANT WASN'T DAMAGED, NOR WAS THE PLASTIC CONTAINER INSIDE. HOWEVER, THE PLASTIC AROUND IMPLANT WAS DAMAGED WITH HOLES, AND THERE WAS BLACK AND WHITE DEBRIS INSIDE THE PLASTIC IN WITH THE IMPLANT. THE SURGEON DID NOT USE THE PRODUCT AND HAD TO OPEN A DIFFERENT IMPLANT TO COMPLETE THE PROCEDURE. 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 13537655 ↗
• 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 9872373 ↗