Taperloc Complete Primary Femoral 51-104200Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00880304499270), received between Apr 14, 2021 and Jan 28, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 28, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE SCRUB TECH NOTICED BLACK RESIDUE INSIDE THE STEM PACKAGING. THE STEM WAS NEVER OPENED OR REMOVED FROM THE PACKAGE ¿ ONLY THE OUTER BOX WAS OPENED. A NEW STEM WAS AVAILABLE TO COMPLETE THE CASE SUCCESSFULLY. NO PATIENT HARM OR IMPACT. NO ADDITIONAL INFORMATION AVAILABLE FOR THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24199342 ↗
• MalfunctionNov 25, 2025Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging; Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23643258 ↗
• MalfunctionNov 25, 2025Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging; Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23643247 ↗
• MalfunctionAug 27, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22903743 ↗
• MalfunctionJun 25, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22326852 ↗
• MalfunctionApr 22, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT THE IMPLANT BROKE THROUGH THE BOX AND WAS PROTRUDING OUT OF THE PACKAGING. 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 21882030 ↗
• MalfunctionFeb 21, 2025Packaging Problem; Packaging Problem

  IT WAS REPORTED WHEN OPENING THE IMPLANT BOX, THE STEM WAS PROTRUDING THROUGH THE PLASTIC AND NO LONGER STERILE OR USABLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21433561 ↗
• MalfunctionMay 28, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING A HIP PROCEDURE, WHEN THE STEM WAS OPENED, THE INNER PACKAGING WAS FOUND COMPROMISED. THE INNER PACKAGING WAS FOUND SLIGHTLY RIPPED NEAR THE DISTAL TIP OF THE STEM AND THE TRUNION OF THE STEM. THE OUTER PACKAGING WAS SLIGHTLY MISSHAPEN, BUT NOT ENOUGH TO INDICATE DAMAGE TO INNER PACKAGING. 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 19404219 ↗
• MalfunctionJun 27, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT THE IMPLANT WAS OPENED, AND THE STEM WAS FOUND POKING THROUGH PLASTIC CONTAINER. THE IMPLANT WAS DEEMED UNSTERILE AND WAS NOT USED ON THE PATIENT. THERE WAS NO REPORTED SURGICAL DELAY. NO ADDITIONAL INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17210798 ↗
• MalfunctionApr 20, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED WHEN INITIALLY SEATING THE STEM INTO THE BONE, THE PATIENT RESULTED IN LIMB LENGTH DISCREPANCY. A LARGER STEM WAS USED AND BOTH THE PATIENTS¿ LIMBS WERE THE SAME LENGTH. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16776099 ↗
• MalfunctionJan 11, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE SURGEON HAD DIFFICULTY WITH THE STEM NOT SEATING TO THE EXACT BROACH SIZE. THE BROACHES WENT DOWN TO WHERE THEY WERE SUPPOSED TO; HOWEVER, THE IMPLANT SAT BETWEEN 1-4 MM PROUD. THE SURGEON WOULD THEN DROP DOWN 2-3 SIZES AND REBROACH. AFTER THAT, THE IMPLANT WOULD SIT IN PLACE. THERE WERE NO PATIENT COMPLICATIONS. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16136872 ↗
• MalfunctionSep 3, 2021Packaging Problem; Packaging Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12421330 ↗
• MalfunctionApr 14, 2021Flaked; Peeled/Delaminated; Flaked; Peeled/Delaminated

  NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11664933 ↗