Taperloc Complete Micro Primary Femoral 51-109070Recalls & 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 Complete femoral implant is an implanted joint replacement component. The 25 reports mostly describe damaged or torn sterile packaging found during stock checks before use, with no patient involved. The reports mention no deaths and 2 injuries. 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
- 24
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00880304513013), received between Jul 6, 2020 and Sep 8, 2026 — classified as 2 injuries, 22 malfunctions.
The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (10 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 Packaging10
- Packaging Problem6
- Device Contaminated During Manufacture or Shipping4
- Manufacturing, Packaging or Shipping Problem4
- Loosening of Implant Not Related to Bone-Ingrowth1
- Migration1
- Nonstandard Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions21
- No Patient Involvement2
- Bone Fracture(s)1
- Failure of Implant1
- Osteopenia/ Osteoporosis1
- Unequal Limb Length1
Recent adverse event reports
The 24 most recent of 24 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 50668361 ↗MalfunctionAug 18, 2026Tear, Rip or Hole in Device Packaging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50306585 ↗MalfunctionAug 18, 2026Tear, Rip or Hole in Device Packaging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50300090 ↗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 25174001 ↗MalfunctionFeb 23, 2026Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping
NO ADDITIONAL INFORMATION AVAILABLE FOR THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24415786 ↗MalfunctionSep 5, 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. NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES REPORTED. NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22975288 ↗MalfunctionJul 29, 2025Tear, 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 AFTER OPENING THE IMPLANT THAT THE INSIDE OF THE PACKAGE HAD BEEN DAMAGED AS IF THE IMPLANT WAS MOVING AROUND INSIDE. IT WAS REPORTED AFTER OPENING THE STEM, PARTICLES WERE PRESENT AND ASSUMED TO BE METAL BUT COULD NOT BE DETERMINED.IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22643579 ↗MalfunctionJul 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 22630145 ↗MalfunctionJun 26, 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 22335377 ↗InjuryMay 1, 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 21941321 ↗MalfunctionMay 1, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT THE WHILE INSPECTING THE PRODUCT, THE PACKAGING WAS FOUND DAMAGED. THERE WAS NO PATIENT INVOLVEMENT. THERE IS NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21941317 ↗MalfunctionApr 28, 2025Nonstandard Device; Nonstandard Device
IT WAS REPORTED THAT THE IMPLANT STEM WAS THE INCORRECT SIZE. THERE WAS A 10 MINUTE DELAY TO GRAB ANOTHER IMPLANT AND COMPLETE THE PROCEDURE. THERE IS NO FURTHER INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21919718 ↗MalfunctionApr 24, 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 THE INNER PACKAGING WAS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT, AND IT WAS REPORTED THAT NO FURTHER INFORMATION COULD BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21900025 ↗MalfunctionFeb 10, 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 21342774 ↗MalfunctionNov 19, 2024Packaging Problem; Packaging Problem
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20722312 ↗MalfunctionSep 26, 2024Packaging Problem; Packaging Problem
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20311196 ↗MalfunctionJul 24, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT WHILE INSPECTING CIRCULATED ITEMS, THE STERILE PACKAGING 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 19818348 ↗MalfunctionJul 12, 2023Packaging Problem; Packaging Problem
IT WAS REPORTED DURING INCOMING INSPECTION AT ZB WAREHOUSE IN JAPAN A TEAM MEMBER FOUND HAIR LIKE DEBRIS IN THE STERILE PACKAGE. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17305005 ↗MalfunctionNov 17, 2022Packaging Problem; Packaging Problem
IT WAS REPORTED THAT DURING AN INCOMING INSPECTION AT A WAREHOUSE IN JAPAN, DEBRIS AND HAIRLIKE DEBRIS WERE FOUND IN THE STERILE PACKAGE. NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15819253 ↗MalfunctionNov 4, 2022Packaging Problem; Packaging Problem
IT WAS REPORTED THERE WAS HAIR-LIKE SUBSTANCE IN THE STERILE PACKAGE. NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15724147 ↗MalfunctionJun 2, 2022Packaging Problem; Packaging Problem
IT WAS REPORTED THAT THE VACUUM SEAL WAS LOST IN THE INNER STERILE PACKAGE OF THE PRODUCT. THERE WAS NO REPORTED HARM OR INJURY TO A PATIENT. 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 14575593 ↗InjuryMay 31, 2022Loosening of Implant Not Related to Bone-Ingrowth; Migration; Loosening of Implant Not Related to Bone-Ingrowth; Migration
IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE OF THE RIGHT HIP APPROXIMATELY ONE MONTH POST IMPLANTATION DUE TO SUBSIDENCE OF THE FEMORAL STEM AFTER LIMB LENGTH DISCREPANCY WAS NOTED. DURING REVISION, A CRACK IN THE UPPER FEMORAL SHAFT AND THE GREATER TROCHANTER DEVELOPED. THESE WERE REPAIRED AND FINAL COMPONENTS WERE REPLACED WITHOUT FURTHER COMPLICATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Bone Fracture(s); Failure of Implant; Osteopenia/ Osteoporosis; Unequal Limb Length
MAUDE report 14548847 ↗MalfunctionJul 17, 2020Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
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 10288357 ↗MalfunctionJul 6, 2020Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
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 10232636 ↗
Other PROSTHESIS, TOE, CONSTRAINED, POLYMER devices
- Taperloc Complete Micro Primary Femoral 51-106100Biomet Orthopedics, LLC · PROSTHESIS, TOE, CONSTRAINED, POLYMER13 reports
- Taperloc Complete Micro Primary Femoral 51-109080Biomet Orthopedics, LLC · PROSTHESIS, TOE, CONSTRAINED, POLYMER9 reports
- Taperloc Complete Micro Primary Femoral 51-106180Biomet Orthopedics, LLC · PROSTHESIS, TOE, CONSTRAINED, POLYMER7 reports
- Taperloc Complete Micro Primary Femoral 51-108070Biomet Orthopedics, LLC · PROSTHESIS, TOE, CONSTRAINED, POLYMER6 reports
- Taperloc Complete Micro Primary Femoral 51-106120Biomet Orthopedics, LLC · PROSTHESIS, TOE, CONSTRAINED, POLYMER4 reports
- RTS M40 SE020In2Bones USA, LLC · Prosthesis, Toe, Constrained, Polymer3 reports
- SWANSON G4260102Wright Medical Technology, Inc. · PROSTHESIS, TOE, CONSTRAINED, POLYMER2 reports
- RTS M40 SE030In2Bones USA, LLC · Prosthesis, Toe, Constrained, Polymer1 report
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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