Taperloc Complete Primary Femoral 51-103100Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00880304489684), received between Jul 31, 2020 and Mar 10, 2023 — classified as 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (7 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.

• MalfunctionMar 10, 2023Difficult to Insert; Difficult to Insert

  NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16520702 ↗
• 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 16136920 ↗
• 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 16136866 ↗
• MalfunctionJul 6, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THERE WAS DEBRIS IN THE STERILE PACKAGE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14935957 ↗
• MalfunctionMay 31, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED BY THE DISTRIBUTORSHIP THAT DEBRIS IN THE STERILE PACKAGING WAS FOUND DURING INCOMING INSPECTION. NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES WERE REPORTED. 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 14551485 ↗
• MalfunctionMar 25, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DURING WAREHOUSE INSPECTION, HAIR-LIKE DEBRIS WAS FOUND 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 13903070 ↗
• MalfunctionMar 11, 2022Device Contaminated During Manufacture or Shipping; Manufacturing, Packaging or Shipping Problem; Device Contaminated During Manufacture or Shipping; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT DURING INSPECTION OF CIRCULATED PRODUCTS IN THE WAREHOUSE, THE PRODUCT WAS IDENTIFIED AS HAVING DAMAGED STERILE PACKAGING. UPON INITIAL REVIEW OF THE PICTURES PROVIDED, A HAIR LIKE SUBSTANCE WAS PRESENT IN THE PACKAGING. NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES REPORTED. 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 13731738 ↗
• 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 13678837 ↗
• MalfunctionOct 21, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED DURING INCOMING INSPECTION AT ONE OF THE WAREHOUSES, DEBRIS WAS FOUND IN THE STERILE PACKAGING. 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 12671574 ↗
• MalfunctionSep 1, 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 12407652 ↗
• MalfunctionMar 18, 2021Difficult to Advance; Difficult to Advance

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11516937 ↗
• MalfunctionOct 26, 2020Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

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

  Patient problems: No Patient Involvement

  MAUDE report 10733633 ↗
• InjuryJul 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY PATIENTS¿ LEGAL COUNSEL THAT THE PATIENT UNDERWENT A RIGHT HIP PROCEDURE. THE PATIENT WAS REVISED SEVEN YEARS LATER DUE TO PAIN, METALLOSIS AND EXTENSIVE PSEUDOTUMOR FORMATION. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Host-Tissue Reaction; Osteolysis; Pain

  MAUDE report 10349527 ↗