Taperloc Complete Micro Primary Femoral 51-107200Recalls & 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
- Adverse event reports
- 14
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00880304513617), received between Jan 7, 2020 and May 20, 2026 — classified as 14 malfunctions.
The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (7 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 Packaging7
- Delivered as Unsterile Product4
- Device Contaminated During Manufacture or Shipping2
- Manufacturing, Packaging or Shipping Problem2
- Packaging Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions12
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 20, 2026Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT DURING INSPECTION OF CIRCULATED STOCK, A DAMAGED STERILE PACKAGING POUCH WAS IDENTIFIED. 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 25236471 ↗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 25174115 ↗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 24190116 ↗MalfunctionNov 10, 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 23511524 ↗MalfunctionAug 11, 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 22778703 ↗MalfunctionAug 6, 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 22725138 ↗MalfunctionOct 3, 2024Packaging Problem; Packaging Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20359681 ↗MalfunctionSep 9, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT DURING SURGERY, THE PACKAGING WAS FOUND CONTAMINATED. THERE WAS A BLACK AND BROWN RESIDUE IN THE STERILE PACKAGING AND THE BAG WAS ALSO NOT VACUUM SEALED LIKE OTHER IMPLANTS. IT SEEMED LIKE THERE WERE HOLES IN THE PACKAGING. SURGERY WAS DELAYED BY A COUPLE MINUTES. THERE WAS NO KNOWN IMPACT OR CONSEQUENCES TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20169396 ↗MalfunctionApr 23, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT BEFORE THE ITEM WAS PUT INTO THE FIELD, THE PLASTIC BARRIER WAS FOUND TO BE DAMAGED. ANOTHER IMPLANT WAS USED TO COMPLETE THE PROCEDURE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19162727 ↗MalfunctionOct 13, 2022Packaging Problem; Packaging Problem
IT WAS REPORTED THAT DURING INSPECTION OF CIRCULATING ITEMS AT THE WAREHOUSE, THE STERILE PACKAGING WAS FOUND TO BE DAMAGED. 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 15600340 ↗MalfunctionJan 26, 2022Tear, 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 UPON OPENING THE PACKAGE, THE NURSE NOTICED THE INTERNAL PLASTIC PACKAGING WAS DAMAGED. UPON INITIAL INSPECTION BY THE MANUFACTURER, THE PACKAGING APPEARS TO BE TORN AND DEBRIS IS PRESENT IN THE STERILE PACKAGING. 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 13357835 ↗MalfunctionApr 23, 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 11715919 ↗MalfunctionMar 27, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
UPON RECEIPT OF ADDITIONAL INFORMATION, IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9888496 ↗MalfunctionJan 7, 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 Known Impact Or Consequence To Patient
MAUDE report 9558511 ↗
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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