Taperloc Complete Micro Primary Femoral 51-106170Recalls & reported problems
Biomet Orthopedics, LLC · Class 2 · Implant
All models of Taperloc Complete Micro Primary Femoral (35)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Biomet Taperloc hip implant comes in a sterile pouch, and the 50 reports all describe packaging problems rather than anything happening to a patient. Most mention tears, holes or punctures in the sterile packaging, or items arriving unsterile, typically spotted during stock inspections before use. No deaths and no injuries were reported. No recalls name this device, and reports have dropped sharply, from 34 in the earlier 12 months to 6 in the most recent.
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
- 52
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 00880304514416), received between Jul 17, 2020 and Sep 25, 2026 — classified as 52 malfunctions.
The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (18 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 Packaging18
- Manufacturing, Packaging or Shipping Problem15
- Packaging Problem14
- Delivered as Unsterile Product6
- Device Contaminated During Manufacture or Shipping1
- Device Damaged Prior to Receipt by User1
Patient problems
- No Clinical Signs, Symptoms or Conditions51
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 52 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Tear, Rip or Hole in Device Packaging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50898438 ↗MalfunctionSep 1, 2026Tear, Rip or Hole in Device Packaging
It was reported that damaged sterile packaging (blister) was identified during inspection of circulated stock prior to use.There was no patient involvement. It was reported no further information available.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50551516 ↗MalfunctionAug 21, 2026Delivered as Unsterile Product; Device Damaged Prior to Receipt by User
It was reported that damaged sterile packaging 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 50370290 ↗MalfunctionMay 14, 2026Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT DURING INSPECTION OF CIRCULATED STOCK, A DEVICE WAS FOUND WITH A DAMAGED STERILE PACKAGING POUCH. 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 25173925 ↗MalfunctionFeb 3, 2026Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT DURING INSPECTION OF CIRCULATED STOCK, 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 24247180 ↗MalfunctionJan 13, 2026Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT DURING INVENTORY INSPECTION, THE PLASTIC PACKAGING SURROUNDING AN IMPLANT WAS FOUND DAMAGED. THE ISSUE WAS IDENTIFIED IN CIRCULATED STOCK PRIOR TO USE, AND THE DEVICE REMAINED IN INVENTORY. 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 24053897 ↗MalfunctionDec 17, 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 23829498 ↗MalfunctionNov 20, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT THE PLASTIC PACKAGING SURROUNDING THE IMPLANT WAS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE. D.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23603559 ↗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 HARM OR IMPACT AS A RESULT. NO ADDITIONAL INFORMATION AVAILABLE FOR THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23404815 ↗MalfunctionOct 24, 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 23383641 ↗MalfunctionOct 21, 2025Delivered as Unsterile Product; Delivered as Unsterile Product
THERE IS NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23349159 ↗MalfunctionSep 30, 2025Packaging Problem; Packaging Problem
NO ADDITIONAL EVENT INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23181449 ↗MalfunctionSep 18, 2025Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging; Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging
NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23083248 ↗MalfunctionSep 8, 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 22991090 ↗MalfunctionAug 20, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
DUE DILIGENCE IS COMPLETE AS MULTIPLE ATTEMPTS WERE MADE; HOWEVER, NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22848533 ↗MalfunctionAug 13, 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 22797236 ↗MalfunctionJul 31, 2025Packaging Problem; Packaging Problem
IT WAS REPORTED THAT THE CIRCULATED ITEMS WERE INSPECTED, AND THE STERILE PACKAGING WAS IDENTIFIED 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 22677820 ↗MalfunctionJul 14, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT WHILE INSPECTING CIRCULATED ITEMS AT THE DISTRIBUTORSHIP, 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 22492737 ↗MalfunctionJul 7, 2025Packaging Problem; Packaging Problem
IT WAS REPORTED THAT THE STERILE PACKAGING WAS DAMAGED DURING INSPECTION OF THE 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 22414165 ↗MalfunctionJul 7, 2025Packaging Problem; Packaging Problem
IT WAS REPORTED THAT THE STERILE PACKAGING WAS DAMAGED DURING INSPECTION OF THE 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 22414149 ↗MalfunctionJul 1, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT DAMAGED STERILE PACKAGING WAS IDENTIFIED IN THE WAREHOUSE DURING THE INSPECTION OF CIRCULATED STOCK ITEMS. NO ADDITIONAL INFORMATION AVAILABLE FOR THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22375595 ↗MalfunctionJun 27, 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 22344259 ↗MalfunctionMay 2, 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 21951261 ↗MalfunctionMay 2, 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 21949857 ↗MalfunctionApr 28, 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. IT WAS REPORTED THAT NO FURTHER INFORMATION COULD BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21920717 ↗
Other PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED devices
- PINNACLE 1217-25-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED735 reports
- NA 1365-52-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED683 reports
- APEX 1246-03-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED3 deaths613 reports
- PINNACLE 1217-20-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 deaths590 reports
- PINNACLE 1217-30-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 death484 reports
- NA 1365-53-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED404 reports
- PINNACLE ALTRX 1221-36-054Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED388 reports
- PINNACLE ALTRX 1221-32-050Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED386 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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