Taperloc Complete Micro Primary Femoral 51-107130Recalls & reported problems
Biomet Orthopedics, LLC · Class 3 · 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 Complete hip stem is an uncemented implant used in hip replacement. The 23 reports that name its identifier mostly describe torn or damaged sterile packaging found during stock checks before use, with no deaths and no injuries. No recalls name this device. Reports fell to 3 from 10 in the year before.
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
- 23
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00880304513495), received between Jul 6, 2020 and Sep 1, 2026 — classified as 23 malfunctions.
The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (13 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 Packaging13
- Delivered as Unsterile Product5
- Manufacturing, Packaging or Shipping Problem4
- Device Contaminated During Manufacture or Shipping1
- Packaging Problem1
- Unsealed Device Packaging1
Patient problems
- No Clinical Signs, Symptoms or Conditions22
- No Patient Involvement1
Recent adverse event reports
The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 1, 2026Tear, Rip or Hole in Device Packaging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50551535 ↗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 24190098 ↗MalfunctionDec 2, 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 23692370 ↗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 23349150 ↗MalfunctionOct 12, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
NO FURTHER INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23275519 ↗MalfunctionSep 17, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT INSPECTED CIRCULATED ITEMS IN STOCK IDENTIFIED THE INNER POUCH DAMAGED. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23078159 ↗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 22397119 ↗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 22375568 ↗MalfunctionJun 23, 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 22309897 ↗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 22170871 ↗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 21738423 ↗MalfunctionFeb 25, 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 WHILE INSPECTING BOXES BEFORE A SURGERY, THE PACKAGING WAS FOUND TO HAVE HOLES. 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 21461078 ↗MalfunctionDec 3, 2024Manufacturing, 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 20833518 ↗MalfunctionMay 21, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19358161 ↗MalfunctionAug 1, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT THE PACKAGING OF A DEVICE HAD A PUNCTURED INNER CONTAINER. 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 17438738 ↗MalfunctionOct 18, 2022Tear, 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 15626696 ↗MalfunctionMay 18, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED DAMAGED STERILE PACKAGING WAS IDENTIFIED WHILE INSPECTED ITEMS IN STOCK. 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 14427816 ↗MalfunctionApr 7, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED UPON INSPECTION OF ITEMS IN STOCK, THE PACKAGES STERILITY WAS DAMAGED. 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 14040256 ↗MalfunctionOct 21, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE PACKAGING MAKING THE IMPLANT NOT STERILE. THE SEALING HAD A HOLE IN THE PACKAGING. IMPLANT WAS NEVER USED. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. 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 12672064 ↗MalfunctionOct 21, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE PACKAGING MAKING THE IMPLANT NOT STERILE. THE SEALING HAD A HOLE IN THE PACKAGING. IMPLANT WAS NEVER USED. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. 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 12671977 ↗MalfunctionSep 27, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12533004 ↗MalfunctionMar 29, 2021Unsealed Device Packaging; Unsealed Device Packaging
IT WAS REPORTED THE INNER STERILE POUCH WAS NOT VACUUM SEALED. SURGEON THOUGHT IT SHOULD HAVE BEEN AND REQUESTED A NEW IMPLANT. 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 11584632 ↗MalfunctionJul 6, 2020Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT DURING AN INVESTIGATION OF CIRCULATED ITEMS, SEVERAL DEVICES WERE IDENTIFIED AS HAVING DEBRIS IN THEIR STERILE PACKAGES. NO PATIENTS WERE INVOLVED. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Patient Involvement
MAUDE report 10232638 ↗
Other Prosthesis, hip, semi-constrained (metal uncemented acetabular component) devices
- BIOLOX DELTA 1365-32-730Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained (metal uncemented acetabular component)93 reports
- RingLoc® Hip System 103531Biomet Orthopedics, LLC · Prosthesis, hip, semi-constrained (metal uncemented acetabular component)1 recall0 reports
- BIOLOX DELTA 1365-28-710Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained (metal uncemented acetabular component)43 reports
- ASPHERE 1365-52-100Depuy (Ireland) · Prosthesis, hip, semi-constrained (metal uncemented acetabular component)39 reports
- ASPHERE 1365-05-100Depuy (Ireland) · Prosthesis, hip, semi-constrained (metal uncemented acetabular component)29 reports
- ASPHERE 1365-06-100Depuy (Ireland) · Prosthesis, hip, semi-constrained (metal uncemented acetabular component)29 reports
- Taperloc Complete Micro Primary Femoral 51-107120Biomet Orthopedics, LLC · Prosthesis, hip, semi-constrained (metal uncemented acetabular component)19 reports
- ASPHERE 1365-53-100Depuy (Ireland) · Prosthesis, hip, semi-constrained (metal uncemented acetabular component)18 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.
How reports and recalls are matched · Editorial policy · Report an error on this page