Taperloc Complete Primary Femoral 51-100060Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00880304498174), received between Apr 23, 2021 and Jul 8, 2026 — classified as 3 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (6 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 8, 2026Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE STERILE PACKAGING WAS FOUND DAMAGED DURING STOCK INSPECTION. 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 25750692 ↗
• InjuryJun 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT A SECOND REVISION DUE TO PAIN. THE PATIENT HAD PREVIOUSLY UNDERGONE A REVISION DUE TO DISLOCATION, AND THE SUBSEQUENT REVISION OCCURRED APPROXIMATELY 7 YEARS AND 9 MONTHS AFTER THE PRIOR REVISION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Pain

  MAUDE report 25503200 ↗
• MalfunctionDec 8, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  THE REPORTER IDENTIFIED A RECURRING PACKAGING ISSUE INVOLVING THE TAPERLOC DEVICE. THE PRODUCT BOX WAS FOUND TO BE SLIGHTLY COMPACTED, WHICH ALLOWED THE STEM TO PROTRUDE THROUGH THE INNER PLASTIC PACKAGING, RESULTING IN A BREACH OF STERILE BARRIER INTEGRITY. THE OUTER PACKAGING WAS OPENED PRIOR TO ANY SURGICAL USE TO ASSESS PRODUCT VIABILITY. NO PATIENTS WERE INVOLVED, AND NO SURGICAL CASES WERE IMPACTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23743242 ↗
• MalfunctionOct 22, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23360417 ↗
• MalfunctionSep 8, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE PACKAGING AROUND THE IMPLANT WAS FOUND DAMAGED. THERE WAS NO PATIENT INVOLVEMENT, AND IT WAS REPORTED NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22991074 ↗
• MalfunctionAug 11, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22778712 ↗
• MalfunctionJun 23, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT WHILE OPENING THE IMPLANT, IT WAS FOUND THAT IT HAD PROTRUDED THROUGH ITS STERILE PACKAGING. A NEW IMPLANT WAS OPENED AND 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 22308318 ↗
• MalfunctionMar 7, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21546805 ↗
• MalfunctionJun 20, 2024Migration; Migration

  NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.

  Patient problems: Failure of Implant

  MAUDE report 19575595 ↗
• InjuryJan 17, 2024Loosening of Implant Not Related to Bone-Ingrowth; Migration; Loosening of Implant Not Related to Bone-Ingrowth; Migration

  IT WAS REPORTED DURING A CLINICAL STUDY A PATIENT UNDERWENT A LEFT HIP REVISION APPROXIMATELY EIGHT MONTHS POST IMPLANTATION DUE TO ASEPTIC LOOSENING, SUBSIDENCE AND A BONE FRACTURE. THE STEM WAS REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Bone Fracture(s)

  MAUDE report 18527275 ↗
• MalfunctionJul 25, 2023Packaging Problem; Packaging Problem

  IT WAS REPORTED BY THE DISTRIBUTORSHIP THAT DURING INCOMING INSPECTION, DEBRIS WAS FOUND IN THE STERILE PACKAGING. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17391089 ↗
• MalfunctionJan 27, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE TAPERLOC STEM WAS FOUND TO BE NOT STERILE. WHEN OPENING THE PACKAGE, THE PRODUCT HAD PENETRATED THE STERILE BAG AND BOX. 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 13366008 ↗
• InjurySep 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN INITIAL HIP ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY ONE MONTH AGO DUE TO PERI PROSTHETIC FRACTURE OF THE FEMUR AFTER A FALL. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 12447720 ↗
• MalfunctionMay 7, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT THE DOCTOR QUESTIONS THE INTEGRITY OF THE STERILE PACKAGING OF THE STEMS. UPON INITIAL INSPECTION, THERE WAS A HAIR-LIKE DEBRIS OUTSIDE THE STERILE POUCH, POTENTIALLY COMPROMISING THE STERILITY OF THE DEVICE. THE DEVICE WAS NOT USED IN SURGERY. NO ADVERSE CONSEQUENCES HAVE BEEN 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 11789366 ↗
• MalfunctionApr 23, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11715920 ↗