Taperloc Complete Primary Femoral 51-100080Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00880304489660), received between Aug 20, 2021 and Apr 16, 2025 — classified as 4 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Packaging Problem” (3 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.

• MalfunctionApr 16, 2025Positioning Problem; Positioning Problem

  SUBSEQUENTLY, THE PATIENT¿S FEMORAL COMPONENT BECAME UNSTABLE AFTER IMPLANTATION. THE FEMORAL COMPONENT WAS MOVING LATERALLY AND DISLOCATING THE HIP. A LARGER FEMORAL COMPONENT WAS USED, AND THE EXPLANTED COMPONENTS WERE DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21849866 ↗
• MalfunctionNov 6, 2023Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT THE STEM WAS TAKEN OUT OF THE UNSTERILE BOX AND WAS FOUND WITH THE PLASTIC PACKAGING CRACKED. THE SURGERY WAS COMPLETED USING ANOTHER DEVICE. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18077472 ↗
• InjuryAug 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY. DURING THIS PROCEDURE THE CALCAR WAS NOTED TO HAVE A NONDISPLACED FRACTURE THAT WAS REPAIRED WITH A CERCLAGE WIRE. NO FURTHER COMPLICATIONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Bone Fracture(s)

  MAUDE report 17487451 ↗
• InjuryJul 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, AT APPROXIMATELY EIGHT MONTHS POST-OP THE PATIENT DEVELOPED PERSISTENT LATERAL THIGH AND GROIN PAIN. TENDONITIS WAS SUSPECTED HOWEVER, THE SURGEON ALSO QUESTIONED IF THERE WAS AN ISSUE WITH THE PRESS-FIT FEMORAL COMPONENT. APPROXIMATELY 9 MONTHS POST-OP, AN INJECTION OF STEROIDS AND LOCAL ANESTHETIC WAS GIVEN UNDER FLUOROSCOPIC GUIDANCE. THE PATIENT HAS SINCE COMPLETED THE STUDY WITH IMPROVEMENT IN PAIN AND ALL IMPLANTS REMAINING IN PLACE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Inflammation; Pain

  MAUDE report 17388239 ↗
• MalfunctionJun 19, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT WHEN THE STEM IMPLANT WAS OPENED, IT WAS FOUND THAT THE INSIDE OF THE PLASTIC PACKAGE WAS BROKEN, COMPROMISING THE IMPLANT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17152352 ↗
• InjuryJan 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT INITIALLY UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY THE PATIENT UNDERWENT REVISION APPROXIMATELY FIVE (5) YEARS LATER DUE TO PERIPROSTHETIC FRACTURE AFTER A FALL. THE FRACTURE WAS SECURED WITH A PLATE AND CABLES, AND THE FEMORAL HEAD, STEM, AND ACETABULAR LINER WERE REPLACED WITHOUT COMPLICATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 16193733 ↗
• MalfunctionDec 13, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE OUTER BOX WAS OPENED, AND IT WAS NOTED THAT THE TAPERLOC STEM HAD PIERCED THROUGH THE INNER BOX. NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15970964 ↗
• MalfunctionAug 31, 2022Positioning Failure; Positioning Failure

  NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15328925 ↗
• MalfunctionJul 21, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED UPON OPENING OUTER BOX, INNER PACKAGING WAS CLEARLY RIPPED WITH TIP OF STEM EXPOSED. 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 15075476 ↗
• InjuryMay 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED DURING AN INITIAL LEFT HIP HEMIARTHROPLASTY, THE PATIENT EXPERIENCED A TROCHANTER FRACTURE. NO FURTHER TREATMENT OR INTERVENTION WAS PROVIDED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Bone Fracture(s)

  MAUDE report 14270395 ↗
• MalfunctionFeb 3, 2022Packaging Problem; Packaging Problem

  IT WAS REPORTED BY THE DISTRIBUTORSHIP THAT PEELING WAS DISCOVERED IN THE SEALING AREA OF THE PRODUCTS. NO ADVERSE EVENTS 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 13446440 ↗
• MalfunctionAug 20, 2021Packaging Problem; Packaging Problem

  IT WAS REPORTED UPON INSPECTION IN THE (B)(6) WAREHOUSE THAT THE TEAM MEMBER FOUND DEBRIS IN THE STERILE PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12347826 ↗