Taperloc Complete Primary Femoral 51-104160Recalls & 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
Quick summary
This is a Biomet Taperloc hip implant used in joint replacement surgery. The 49 reports mostly describe packaging problems — torn or punctured sterile packaging, and stock arriving unsterile or contaminated — usually found during inventory inspection with no patient involved. Four reports involve injuries, including pain and muscle or tendon damage, and no deaths. No recalls name this device. Reports fell from 24 in the previous 12 months to 7 in the most recent 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 48
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 00880304491854), received between Mar 24, 2020 and Sep 18, 2026 — classified as 4 injuries, 44 malfunctions.
The most frequently reported specific device problem is “Packaging Problem” (14 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
- Packaging Problem14
- Tear, Rip or Hole in Device Packaging12
- Delivered as Unsterile Product9
- Manufacturing, Packaging or Shipping Problem8
- Device Contaminated During Manufacture or Shipping4
- Adverse Event Without Identified Device or Use Problem3
- Difficult to Insert1
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- No Clinical Signs, Symptoms or Conditions40
- No Known Impact Or Consequence To Patient2
- No Patient Involvement2
- Pain2
- Bursitis1
- Extraskeletal ossification1
- Failure of Implant1
- Muscle/Tendon Damage1
Recent adverse event reports
The 25 most recent of 48 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 18, 2026Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50828440 ↗MalfunctionFeb 17, 2026Tear, Rip or Hole in Device Packaging
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24370191 ↗MalfunctionJan 13, 2026Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT DURING INSPECTION OF CIRCULATED INVENTORY, A STERILE PACKAGE WAS FOUND DAMAGED. 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 24052523 ↗MalfunctionJan 5, 2026Tear, Rip or Hole in Device Packaging
NO ADDITIONAL INFORMATION AVAILABLE FOR THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23961329 ↗MalfunctionDec 8, 2025Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging; Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT DURING STOCK INSPECTION, THE STERILE PACKAGING WAS FOUND DAMAGED. 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 23752442 ↗MalfunctionNov 26, 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 23657824 ↗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 23406432 ↗MalfunctionAug 19, 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 22838916 ↗MalfunctionAug 18, 2025Positioning Failure; Positioning Failure
IT WAS REPORTED THAT THE STEM SAT 5MM PROUD COMPARED TO THE FINAL BROACH. 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 22827060 ↗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 22778719 ↗MalfunctionJul 14, 2025Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT THE STERILE PACKAGING WAS FOUND DAMAGED WHILE INSPECTING STOCK. THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22503416 ↗MalfunctionJul 14, 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 22492727 ↗MalfunctionJul 14, 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 22492724 ↗MalfunctionJul 3, 2025Packaging Problem; Packaging Problem
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22397121 ↗MalfunctionJun 10, 2025Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT THE STERILE PACKAGING WAS FOUND DAMAGED WHILE INSPECTING STOCK. THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22175231 ↗MalfunctionJun 9, 2025Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT THE STERILE PACKAGING WAS FOUND DAMAGED WHILE INSPECTING STOCK. THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22170858 ↗MalfunctionJun 2, 2025Packaging Problem; Packaging Problem
IT WAS REPORTED THAT DURING INSPECTION OF THE CIRCULATED ITEMS THAT THE INNER POUCH WAS CONSIDERED 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 22122958 ↗MalfunctionApr 23, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED UPON OPENING THE IMPLANT THAT THE INNER PLASTIC PACKAGING WAS FOUND TO BE CRACKED. A STANDARD OFFSET STEM OF THE SAME SIZE WAS USED INSTEAD. NO KNOWN IMPACT OR CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21893714 ↗MalfunctionApr 1, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT WHEN 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 21741686 ↗InjuryApr 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT 10 YEARS POST IMPLANTATION, THE PATIENT EXPERIENCED LEFT LATERAL PAIN CONSISTENT WITH TROCHANTER BURSITIS. PATIENT TOOK OVER THE COUNTER MEDICATION (NSAIDS) AND OUTPATIENT THERAPY WERE ADMINISTERED AND THE IMPLANTS REMAIN IMPLANTED. THERE IS NO FURTHER INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Bursitis; Pain
MAUDE report 21737982 ↗MalfunctionMar 14, 2025Packaging Problem; Packaging Problem
IT WAS REPORTED THAT THE CIRCULATED ITEMS WERE INSPECTED AND THAT THE STERILE PACKAGING 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 21604758 ↗MalfunctionMar 12, 2025Delivered as Unsterile Product; Delivered as Unsterile Product
UPON RECEIVING ADDITIONAL INFORMATION OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE AS THIS PRODUCT STERILITY WAS NOT BREACHED. THE INITIAL REPORT SHOULD BE VOIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21584908 ↗MalfunctionMar 12, 2025Packaging Problem; Packaging Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21584391 ↗MalfunctionMar 10, 2025Difficult to Insert; Separation Failure; Difficult to Insert; Separation Failure
THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21558599 ↗MalfunctionFeb 21, 2025Packaging Problem; Packaging Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21433553 ↗
Other Prosthesis, hip, semi-constrained, metal/polymer, uncemented devices
- LFIT 6260-9-136Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, uncemented166 reports
- Trident 623-00-36EHowmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, uncemented112 reports
- Accolade 6021-0435Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, uncemented88 reports
- EXETER 0580-1-044Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, uncemented1 recall22 reports
- Endo-Model SL Knee Prosthesis System 16-2840/02WALDEMAR LINK GmbH & Co. KG · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented1 recall17 reports
- Endo-Model SL Knee Prosthesis System 16-2840/05WALDEMAR LINK GmbH & Co. KG · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented1 recall12 reports
- Trident 623-10-36EHowmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, uncemented57 reports
- LFIT 6260-9-336Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, uncemented56 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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