Taperloc Complete Primary Femoral 51-103090Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00880304498334), received between Jan 27, 2021 and Dec 8, 2025 — classified as 3 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (2 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• 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 23743802 ↗
• MalfunctionMay 20, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT WHEN THE STEM WAS OPENED TO THE SURGICAL FIELD, THERE WAS A HAIR DISCOVERED INSIDE THE PACKAGING. THE STEM WAS NOT 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 19352216 ↗
• InjuryJan 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT HAD AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT BEGAN TO EXPERIENCE MODERATE PAIN WITH A DECREASE IN RANGE OF MOTION APPROXIMATELY 6 YEARS POST-IMPLANTATION. THE PATIENT RECEIVED CORTISONE INJECTIONS FOR RIGHT INGUINAL PAIN, EXACERBATED WITH ACTIVE HIP FLEXION. THE CORTISONE INJECTIONS ALLEVIATED THE PAIN FOR THREE WEEKS BUT IS NOW REPORTING SEVERE PAIN. NO DEFINITIVE PLANNED INTERVENTION HAS BEEN REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Inflammation; Loss of Range of Motion; Pain

  MAUDE report 18450286 ↗
• MalfunctionJul 24, 2023Difficult to Insert; Difficult to Insert

  THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17379649 ↗
• InjuryOct 21, 2022Migration or Expulsion of Device; Loosening of Implant Not Related to Bone-Ingrowth; Migration or Expulsion of Device; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HIP REVISION APPROXIMATELY FIVE MONTHS¿ POST IMPLANTATION DUE TO ASEPTIC LOOSENING, POOR BONE QUALITY, AND SUSPECTED PROSTHETIC JOINT INFECTION, NOT CLINICALLY CONFIRMED. DURING THE REVISION NOTED VASCULITIS, SCAR TISSUE AND SUBSIDENCE OF FEMORAL COMPONENT. THE STEM, LINER, AND HEAD WERE EXCHANGED WITHOUT COMPLICATIONS. THE ACETABULAR COMPONENT REMAINED IMPLANTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Inflammation; Osteopenia/ Osteoporosis; Pain; Scar Tissue

  MAUDE report 15650118 ↗
• MalfunctionSep 13, 2022Packaging Problem; Packaging Problem

  IT WAS REPORTED DURING INCOMING INSPECTION THAT A TEAM MEMBER FOUND HAIR-LIKE DEBRIS IN THE STERILE PACKAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15409946 ↗
• MalfunctionMay 23, 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 WHEN OPENING THE PACKAGE PARTICLES WERE IN THE INNER PACKAGE AND THE IMPLANT HAD POKED THROUGH THE PLASTIC SLEEVE. 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 14469044 ↗
• InjuryMay 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY FOURTEEN (14) DAYS POST IMPLANTATION OF THE RIGHT HIP, THE PATIENT DEVELOPED A PULMONARY EMBOLISM, REQUIRING A ONE DAY HOSPITALIZATION. PULMONARY EMBOLISM RESOLVED WITHOUT FURTHER COMPLICATION. UPON FOLLOW-UP, THE PATIENT REPORTED NO PROBLEMS AND WAS VERY SATISFIED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Pulmonary Embolism

  MAUDE report 14291013 ↗
• MalfunctionJan 27, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DURING INCOMING 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 Patient Involvement

  MAUDE report 11236121 ↗