TAPERLOC COMPLETE XR 123 FEMORAL 51-105130Recalls & reported problems
Biomet Orthopedics, LLC · Class 2 · Implant
All models of TAPERLOC COMPLETE XR 123 FEMORAL (15)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is a Biomet Taperloc Complete XR hip implant, used in hip replacement surgery. Most of the 28 reports describe problems with the sterile packaging — pouches arriving torn, punctured, or otherwise damaged, with some product not sterile or contaminated. There are no deaths and 1 injury, a femoral fracture found right after implantation. No recalls name this device, and reports have fallen from 11 to 6 in the past 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
- 29
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00880304517141), received between Jun 29, 2020 and Sep 8, 2026 — classified as 1 injury, 28 malfunctions.
The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (8 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 Packaging8
- Manufacturing, Packaging or Shipping Problem7
- Packaging Problem7
- Delivered as Unsterile Product5
- Device Contaminated During Manufacture or Shipping3
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions26
- No Known Impact Or Consequence To Patient1
- No Patient Involvement1
- Periprosthetic fracture1
Recent adverse event reports
The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 8, 2026Tear, Rip or Hole in Device Packaging
It was reported that damaged sterile packaging and pouch were 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 50667567 ↗MalfunctionAug 26, 2026Tear, Rip or Hole in Device Packaging
It was reported that a device¿s sterile packaging was found damaged.The issue was identified during inspection of circulated stock, where a damaged sterile pouch was observed.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 50452574 ↗MalfunctionJul 16, 2026Tear, Rip or Hole in Device Packaging
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 25838293 ↗MalfunctionNov 17, 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 23575723 ↗MalfunctionNov 15, 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 23564214 ↗InjuryNov 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON THE SAME DAY AS IMPLANTATION, A FEMORAL FRACTURE WAS IDENTIFIED VIA POST-OP X-RAY. A REVISION IS PLANNED ON AN UNKNOWN DATE. TO DATE, NO KNOWN REVISION HAS TAKEN PLACE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Periprosthetic fracture
MAUDE report 23545849 ↗MalfunctionNov 4, 2025Packaging Problem; Packaging Problem
NO ADDITIONAL EVENT INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23468186 ↗MalfunctionOct 21, 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 23349144 ↗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 22838845 ↗MalfunctionJun 18, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
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 22284053 ↗MalfunctionJun 13, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
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 22201382 ↗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 22170874 ↗MalfunctionMay 15, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THE CIRCULATED ITEMS WERE INSPECTED AND THAT THE INNER POUCH WAS FOUND 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 22025729 ↗MalfunctionApr 29, 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 21930977 ↗MalfunctionApr 29, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21930972 ↗MalfunctionApr 1, 2025Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT DURING INSPECTION OF STOCK, THE 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 21738426 ↗MalfunctionFeb 6, 2025Packaging Problem; Packaging Problem
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21324193 ↗MalfunctionJan 29, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21264056 ↗MalfunctionJun 27, 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 19624189 ↗MalfunctionOct 24, 2023Packaging Problem; Packaging Problem
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17995823 ↗MalfunctionJul 31, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17423580 ↗MalfunctionFeb 16, 2023Packaging Problem; Packaging Problem
DURING THE INVESTIGATION OF THE REPORTED EVENT THE PRODUCT WAS FOUND TO BE CONFORMING AND STERILITY WAS NOT COMPROMISED. THEREFORE, THIS IS NO LONGER A REPORTABLE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16392753 ↗MalfunctionFeb 10, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16352691 ↗MalfunctionNov 8, 2022Packaging Problem; Packaging Problem
IT WAS REPORTED THAT DURING INSPECTION AT THE WAREHOUSE, THE STERILE PACKAGING WAS FOUND TO BE DAMAGED. IT IS UNKNOWN AT THIS TIME IF STERILITY HAS BEEN COMPROMISED. THERE WAS NO PATIENT INVOLVEMENT. 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 15754296 ↗MalfunctionNov 7, 2021Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping; Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT DURING AN INSPECTION OF INVENTORY IN THE WAREHOUSE, DEBRIS IN THE STERILE PACKAGING WAS FOUND. UPON FURTHER INSPECTION BY THE MANUFACTURER, THERE WAS DAMAGE TO STERILE BLISTER AND POUCH WITH DEBRIS INSIDE THE STERILE PACKAGING WHICH IS CONSISTENT WITH THE APPEARANCE OF FOAM DEBRIS FROM THE FOAM PACKAGING AND THE POROUS COATING. STERILITY HAS BEEN COMPROMISED. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES WERE REPORTED. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12758018 ↗
Other Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-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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