Taperloc Complete Primary Femoral 51-100050Recalls & reported problems
Biomet Orthopedics, LLC · Class 2 · Implant
All models of Taperloc Complete Primary Femoral (40)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00880304498167), received between Apr 29, 2020 and Jul 28, 2026 — classified as 1 injury, 19 malfunctions.
The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (9 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.
Reports received per month
Most reported problems
Device problems
- Tear, Rip or Hole in Device Packaging9
- Manufacturing, Packaging or Shipping Problem5
- Packaging Problem4
- Device Contaminated During Manufacture or Shipping2
- Delivered as Unsterile Product1
- Detachment of Device or Device Component1
- Device Dislodged or Dislocated1
Patient problems
- No Clinical Signs, Symptoms or Conditions17
- No Known Impact Or Consequence To Patient2
- Joint Dislocation1
Recent adverse event reports
The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 28, 2026Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50060281 ↗MalfunctionFeb 23, 2026Device Contaminated During Manufacture or Shipping
NO ADDITIONAL INFORMATION AVAILABLE FOR THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24415625 ↗MalfunctionDec 9, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23759559 ↗MalfunctionOct 28, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT THE TAPERLOC IMPLANTS WERE POKING THROUGH THE PACKAGING. NO PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION AVAILABLE FOR THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23406379 ↗MalfunctionAug 28, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
NO ADDITIONAL INFORMATION AVAILABLE FOR THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22911158 ↗MalfunctionApr 18, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT WHILE INSPECTING THE PRODUCT, THE STERILE PACKAGING WAS FOUND DAMAGED. THERE WAS NO PATIENT INVOLVEMENT. THERE IS NO FURTHER INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21864252 ↗MalfunctionMar 28, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT WHILE INSPECTING THE PRODUCT, THE INNER POUCH WAS FOUND TORN. THE WAS NO PATIENT INVOLVEMENT. THERE IS NO FURTHER INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21720248 ↗MalfunctionMar 12, 2025Packaging Problem; Packaging Problem
IT WAS REPORTED THAT THE CIRCULATED ITEMS WERE INSPECTED, AND THE STERILE PACKAGING WAS DETERMINED TO BE DAMAGED. THERE WAS NO PATIENT INVOLVEMENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21584613 ↗MalfunctionMar 7, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT WHILE INSPECTING CIRCULATED ITEMS, IT WAS FOUND THAT THE STERILE PACKAGING WAS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT, AND NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21546922 ↗MalfunctionFeb 7, 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 21332484 ↗MalfunctionFeb 7, 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 21332374 ↗MalfunctionDec 2, 2024Manufacturing, 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 20817532 ↗MalfunctionJun 17, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED BY THE DISTRIBUTORSHIP THAT DURING INCOMING INSPECTION, THE ITEMS WERE FOUND TO BE NONCONFORMING. STERILITY HAS BEEN BREACHED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19546845 ↗MalfunctionDec 22, 2023Packaging Problem; Packaging Problem
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18387639 ↗MalfunctionDec 12, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED CIRCULATED ITEMS IN STOCK WERE INSPECTED AND THE STERILE PACKAGE WAS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15958330 ↗MalfunctionNov 17, 2022Packaging Problem; Packaging Problem
IT WAS REPORTED THAT DURING INCOMING INSPECTION, DEBRIS WAS FOUND IN THE STERILE PACKAGE. THERE WAS NO PATIENT INVOLVEMENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15815503 ↗MalfunctionAug 3, 2022Tear, Rip or Hole in Device Packaging; Packaging Problem; Tear, Rip or Hole in Device Packaging; Packaging Problem
IT WAS REPORTED THAT A DEVICE WAS RETURNED WITH PACKAGING DAMAGE AND THE STERILITY BARRIER POTENTIALLY COMPROMISED. THERE IS NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15159792 ↗InjuryFeb 14, 2022Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated
IT WAS REPORTED THE PATIENT UNDERWENT A HIP REVISION APPROXIMATELY 10 DAYS POST IMPLANTATION DUE TO DISLOCATION AND THE STEM TAPER UNABLE TO HOLD THE HEAD. NO ADDITIONAL INFORMATION
Patient problems: Joint Dislocation
MAUDE report 13523478 ↗MalfunctionOct 20, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT DURING A HEMI HIP ARTHROPLASTY THE SURGEON FOUND THE STEMS PROTRUDING OUT OF THE PLASTIC BLISTERS AND STUCK IN THE UNSTERILE CARDBOARD BOX. SURGEON HAD TO DOWNSIZE IN ORDER TO GET STEM TO FIT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10706604 ↗MalfunctionApr 29, 2020Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
NO ADDITIONAL INFORMATION ON REPORTED EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10009344 ↗
Other Prosthesis, hip, hemi-, femoral, metal devices
- UHR UH1-48-28Howmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal2 recalls3 reports
- "UNITED" USTAR II Knee System 2515-3111United Orthopedic Corp. · Prosthesis, Hip, Hemi-, Femoral, Metal2 recalls0 reports
- "UNITED" USTAR II Knee System 2515-3213United Orthopedic Corp. · Prosthesis, Hip, Hemi-, Femoral, Metal2 recalls0 reports
- STAGEONE 431207Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal2 recalls0 reports
- "UNITED" USTAR II Knee System 2515-3115United Orthopedic Corp. · Prosthesis, Hip, Hemi-, Femoral, Metal2 recalls0 reports
- ACTIS 101011050Depuy (Ireland) · Prosthesis, hip, hemi-, femoral, metal73 reports
- UHR UH1-46-26Howmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal1 recall11 reports
- UHR UH1-45-26Howmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal1 recall11 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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