Taperloc Complete Micro Primary Femoral 51-106150Recalls & 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 stem is a metal implant used in hip replacement surgery. Most of the 53 reports describe problems with the sterile packaging — pouches arriving torn, punctured, contaminated, or otherwise damaged, sometimes discovered during stock inspection before any patient was involved. Reports also mention the device arriving unsterile and being hard to insert. There are 53 reports in total, 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
- 53
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 00880304514379), received between Jan 7, 2020 and Sep 25, 2026 — classified as 1 injury, 52 malfunctions.
The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (28 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 Packaging28
- Packaging Problem8
- Device Contaminated During Manufacture or Shipping7
- Delivered as Unsterile Product6
- Manufacturing, Packaging or Shipping Problem6
- Device Damaged Prior to Receipt by User1
- Difficult to Insert1
Patient problems
- No Clinical Signs, Symptoms or Conditions48
- No Known Impact Or Consequence To Patient3
- No Patient Involvement2
Recent adverse event reports
The 25 most recent of 53 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Tear, Rip or Hole in Device Packaging
It was reported that during inspection of circulated stock inventory, a sterile packaging pouch 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 50898167 ↗MalfunctionSep 2, 2026Tear, Rip or Hole in Device Packaging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50571121 ↗MalfunctionSep 2, 2026Tear, Rip or Hole in Device Packaging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50571120 ↗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 50370202 ↗MalfunctionAug 18, 2026Tear, Rip or Hole in Device Packaging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50306595 ↗MalfunctionAug 18, 2026Tear, Rip or Hole in Device Packaging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50306485 ↗MalfunctionAug 18, 2026Tear, Rip or Hole in Device Packaging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50300214 ↗MalfunctionAug 13, 2026Tear, Rip or Hole in Device Packaging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50238906 ↗MalfunctionAug 13, 2026Tear, Rip or Hole in Device Packaging
It was reported that damaged sterile packaging was identified during stock inspection. During inspection of circulated items, the sterile packaging pouch was found damaged. There was no patient involvement. It was reported no further information available.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50238275 ↗MalfunctionAug 13, 2026Tear, Rip or Hole in Device Packaging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50238248 ↗MalfunctionJul 28, 2026Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50060290 ↗MalfunctionFeb 19, 2026Tear, Rip or Hole in Device Packaging
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 24388106 ↗MalfunctionFeb 19, 2026Tear, Rip or Hole in Device Packaging
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 24388025 ↗MalfunctionFeb 17, 2026Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT DURING INSPECTION OF CIRCULATING 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 24370202 ↗MalfunctionJan 28, 2026Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT DAMAGED STERILE PACKAGING WAS IDENTIFIED DURING INSPECTION OF CIRCULATED STOCK ITEMS. NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION AVAILABLE FOR THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24200189 ↗MalfunctionJan 27, 2026Delivered 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 24190044 ↗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 24053908 ↗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 24052492 ↗MalfunctionDec 17, 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 23829455 ↗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 23759600 ↗MalfunctionOct 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 23404894 ↗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 23349148 ↗MalfunctionSep 29, 2025Packaging Problem; Packaging Problem
NO ADDITIONAL EVENT INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23165532 ↗MalfunctionSep 29, 2025Packaging Problem; Packaging Problem
IT WAS REPORTED THAT THE CIRCULATED ITEMS WERE INSPECTED, AND IT WAS IDENTIFIED 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 23165504 ↗MalfunctionSep 17, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
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 23074218 ↗
Other Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented devices
- STAGEONE 431209Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented2 recalls0 reports
- SELF CENTERING 1035-45-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented84 reports
- LFIT 6260-9-036Howmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented80 reports
- ACTIS 101011060Depuy (Ireland) · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented66 reports
- RINGLOC BI-POLAR HIP SYSTEM 11-165228Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall1 death12 reports
- SELF CENTERING 1035-44-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented60 reports
- TANDEM 71324046Smith & Nephew, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall9 reports
- TAPERLOC COMPLETE XR 123 MICRO FEMORAL 51-145170Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented59 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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