Taperloc Complete Primary Femoral 51-101060Recalls & 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 Biomet Taperloc hip stem is an uncemented implant used in hip replacement. Reports mostly describe torn or damaged sterile packaging found during stock checks before use, with no patient involved. There are 23 reports naming its identifier, with no deaths and 1 injury. No recalls name this device.
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
- 20
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00880304499072), received between May 7, 2020 and Sep 15, 2026 — classified as 2 injuries, 18 malfunctions.
The most frequently reported specific device problem is “Packaging Problem” (7 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 Problem7
- Tear, Rip or Hole in Device Packaging4
- Manufacturing, Packaging or Shipping Problem3
- Adverse Event Without Identified Device or Use Problem2
- Delivered as Unsterile Product2
- Device Contaminated During Manufacture or Shipping2
- Unsealed Device Packaging1
Patient problems
- No Clinical Signs, Symptoms or Conditions15
- Bone Fracture(s)2
- No Patient Involvement2
- Hematoma1
- No Consequences Or Impact To Patient1
- Pain1
- Swelling/ Edema1
Recent adverse event reports
The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 15, 2026Tear, Rip or Hole in Device Packaging
It was reported that damaged sterile packaging pouch was identified during inspection of circulated stock items. No additional information available for the reported event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50772791 ↗InjuryApr 20, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING A LEFT HIP PROCEDURE, THE FEMUR FRACTURED WHILE IMPLANTING THE STEM. DUE TO THE FRACTURED FEMUR, THERE WAS ABOUT A 1.5 HOUR DELAY TO IMPLANT A DIFFERENT HIP SYSTEM WITH A PLATE AND CABLES. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Bone Fracture(s)
MAUDE report 24927128 ↗MalfunctionDec 2, 2025Unsealed Device Packaging; Unsealed Device Packaging
NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23692281 ↗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 23406412 ↗MalfunctionSep 10, 2025Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging; Delivered as Unsterile Product; 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 23014754 ↗MalfunctionJul 14, 2025Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT THE STEM WAS OUT OF THE INNER STERILE BOX UPON OPENING. 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 22495631 ↗MalfunctionJul 3, 2025Packaging Problem; Packaging Problem
IT WAS REPORTED THAT THE STERILE PACKAGING WAS DAMAGED DURING INSPECTION OF CIRCULATED ITEMS. THERE WAS NO PATIENT INVOLVEMENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22397112 ↗MalfunctionApr 29, 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 IT WAS REPORTED NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21928333 ↗InjuryMar 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Bone Fracture(s); Hematoma; Pain; Swelling/ Edema
MAUDE report 21508835 ↗MalfunctionFeb 24, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT WHILE INSPECTING STOCK AT THE DISTRIBUTORSHIP, THE PACKAGING WAS FOUND TO HAVE INNER POUCH DAMAGE. THERE IS NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21453115 ↗MalfunctionFeb 24, 2025Packaging Problem; Packaging Problem
IT WAS REPORTED THAT THE 6 HIGH OFFSET TAPERLOC COMPLETE WAS OPENED AND THE STEM WAS STICKING OUT OF THE STERILE PACKAGING. THE STEM HAD PUNCHED A HOLE THROUGH THE BOX AND PLASTIC. THERE WAS NO PATIENT INVOLVEMENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21445654 ↗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 21332480 ↗MalfunctionOct 4, 2024Packaging Problem; Packaging Problem
IT WAS REPORTED THE OUTSIDE PACKAGING WAS NOT DAMAGED, BUT THE INSIDE PACKAGING WAS DAMAGED UPON OPENING. THERE WAS NO DEBRIS IN THE PACKAGING. THE CASE WAS COMPLETED WITH ANOTHER DEVICE. NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20369849 ↗MalfunctionSep 19, 2023Manufacturing, 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 17772427 ↗MalfunctionDec 29, 2022Packaging Problem; Packaging Problem
IT WAS REPORTED THAT DURING INSPECTION OF STOCK, THE INNER POUCH WAS FOUND TORN. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16069426 ↗MalfunctionDec 12, 2022Packaging Problem; Packaging Problem
UPON REASSESSMENT OF THE REPORTED EVENT, IT HAS BEEN DETERMINED THAT THE DEVICE STERILITY HAS NOT BEEN COMPROMISED. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15961847 ↗MalfunctionDec 16, 2021Packaging Problem; Packaging Problem
IT WAS REPORTED DISTRIBUTOR INSPECTED CIRCULATED ITEMS AND IDENTIFIED THE STERILE PACKAGE DAMAGED. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13021713 ↗MalfunctionFeb 18, 2021Packaging Problem; Packaging Problem
IT WAS REPORTED THAT THE DURING INVESTIGATION OF PRODUCT AT THE DISTRIBUTORSHIP, THE PACKAGING WAS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11345919 ↗MalfunctionJun 26, 2020Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Patient Involvement
MAUDE report 10201125 ↗MalfunctionMay 7, 2020Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
NOT REPORTABLE: UPON INVESTIGATION, IT HAS BEEN DETERMINED THAT THE DEBRIS IN THE STERILE PACKAGING MEETS THE ACCEPTABLE CRITERIA AND PRODUCT IS CONFORMING TO SPECIFICATIONS. EVENT IS NO LONGER CONSIDERED REPORTABLE, AND INITIAL REPORT SHOULD BE VOIDED.
Patient problems: No Patient Involvement
MAUDE report 10036431 ↗
Other Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate devices
- Novation 130-32-51Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls156 reports
- Novation 130-36-53Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls79 reports
- CORAIL 3L92511Depuy (Ireland) · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate158 reports
- Acumatch A Series 138-36-29Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate3 recalls1 report
- Novation 136-32-51Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls43 reports
- Novation 130-32-53Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls33 reports
- Novation 132-32-51Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls26 reports
- Novation 136-36-53Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls22 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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