Taperloc Complete Primary Femoral 51-103140Recalls & reported problems
Biomet Orthopedics, LLC · Class 2 · Implant
All models of Taperloc Complete Primary Femoral (40)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Biomet Taperloc Complete hip implant is a metal stem used in hip replacement. The 24 reports mostly describe damaged or torn sterile packaging found during stock checks, with no patient involved. The records include no deaths and 3 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
- 22
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00880304491816), received between Mar 23, 2020 and Aug 10, 2026 — classified as 3 injuries, 19 malfunctions.
The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (8 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 Packaging8
- Delivered as Unsterile Product5
- Manufacturing, Packaging or Shipping Problem4
- Device Contaminated During Manufacture or Shipping3
- Packaging Problem2
- Adverse Event Without Identified Device or Use Problem1
- Device Damaged Prior to Use1
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions16
- Pain2
- Ambulation or Postural Difficulties1
- Bone Fracture(s)1
- Bursitis1
- Failure of Implant1
- Joint Dislocation1
- No Information1
Recent adverse event reports
The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 10, 2026Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging
It was reported that damaged sterile packaging of a pouch was identified during inspection of circulated stock. 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 50192030 ↗MalfunctionDec 16, 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 23821700 ↗MalfunctionOct 22, 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 23360418 ↗MalfunctionJul 22, 2025Packaging Problem; Packaging Problem
NO ADDITIONAL EVENT INFORMATION AVAILABLE TO REPORT AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22566724 ↗MalfunctionJul 17, 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 THE INNER POUCH PACKAGING OF THE IMPLANT WAS FOUND DAMAGED. THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22531050 ↗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 21900026 ↗MalfunctionMar 19, 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 WHEN THE IMPLANT WAS OPENED DURING SURGERY, THE STEM WAS POPPED OUT OF THE BOX. THERE WAS A ONE-MINUTE DELAY TO GET ANOTHER IMPLANT. 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 21642479 ↗MalfunctionNov 18, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT WHILE INSPECTING STOCK, THE STERILE PACKAGING WAS FOUND DAMAGED. THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20707923 ↗MalfunctionNov 8, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20639771 ↗MalfunctionAug 15, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THE DURING AN INSPECTION OF THE STOCK IN CIRCULATION, THE STERILE PACKAGING WAS FOUND TO BE DAMAGED. THERE WAS NO PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19992325 ↗MalfunctionMay 22, 2024Positioning Failure; Positioning Failure
NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19374783 ↗InjuryApr 16, 2024Migration; Migration
IT WAS REPORTED BY THE PMI GROUP THAT A PATIENT UNDERWENT A RIGHT HIP ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT IS BEING CONSIDERED FOR A PMI PRODUCT ON AN UNKNOWN DAY FOR AN UNKNOWN REASON. X-RAYS RECEIVED AND REVIEWED, NOTING LOOSENING OF THE ACETABULAR COMPONENT, SUBSIDENCE OF THE FEMORAL COMPONENT, DISLOCATION OF THE FEMORAL HEAD, AND BONE FRACTURE OF THE ACETABULUM. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Bone Fracture(s); Joint Dislocation
MAUDE report 19116679 ↗InjuryMar 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT APPROXIMATELY 3 MONTHS POST IMPLANTATION OF A RIGHT TOTAL HIP ARTHROPLASTY, THE PATIENT BEGAN TO EXPERIENCE RIGHT LATERAL PAIN. THE PAIN WAS THOUGHT TO BE ATTRIBUTED TO TROCHANTER BURSITIS AND IT BAND IRRITATION. THE PATIENT WAS INSTRUCTED TO USE ICING TECHNIQUES, TOPICAL CREAMS, AND WAS PRESCRIBED MELOXICAM AND PHYSICAL THERAPY. AT THE ONE-YEAR POST-OPERATIVE, THE PATIENT IS PROGRESSING WITHOUT COMPLICATIONS, AND ALL IMPLANTS REMAIN IN PLACE. NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: Bursitis; Pain
MAUDE report 18876664 ↗MalfunctionJan 10, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18487198 ↗InjuryMar 7, 2023Fracture; Fracture
THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.
Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Pain
MAUDE report 16496319 ↗MalfunctionFeb 16, 2023Packaging Problem; Packaging Problem
IT WAS REPORTED WHILE INSPECTING THE CIRCULATING ITEMS IN STOCK, THE STERILE PACKAGING WAS FOUND TO BE DAMAGED. THERE WAS NO PATIENT INVOLVEMENT. IT WAS REPORTED THAT NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16392751 ↗MalfunctionNov 22, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED DURING THE INCOMING INSPECTION AT ZB WAREHOUSE IN JAPAN A TEAM MEMBER FOUND HAIR LIKE DEBRIS IN THE STERILE PACKAGE. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15843045 ↗MalfunctionNov 17, 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 15821058 ↗MalfunctionJun 22, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
UPON RECEIPT OF ADDITIONAL INFORMATION, IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CONTAIN ANY DEBRIS THAT WOULD COMPROMISE STERILITY. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12043085 ↗MalfunctionNov 26, 2020Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT DURING A TOTAL HIP PROCEDURE THE IMPLANT OUTER PACKAGE WAS OPENED AND INSIDE PLASTIC COVER WAS NOTICED TO HAVE A HOLE IN THE CORNER. IMPLANT NEVER MADE IT ONTO THE STERILE FIELD. ANOTHER IDENTICAL IMPLANT THAT WAS ALREADY AT THE FACILITY WAS OPENED IN ITS PLACE WITH NO DELAY TO THE SURGERY. NO ADDITIONAL INFORMATION.
Patient problems: No Information
MAUDE report 10909582 ↗MalfunctionNov 3, 2020Device Damaged Prior to Use; Tear, Rip or Hole in Device Packaging; Device Damaged Prior to Use; Tear, Rip or Hole in Device Packaging
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10777696 ↗MalfunctionMar 23, 2020Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT DURING INVESTIGATION OF STOCK PRODUCTS, DEBRIS WAS NOTIFIED WITHIN THE STERILE PACKAGING. THERE WAS NO PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: No Patient Involvement
MAUDE report 9866364 ↗
Other Prosthesis, hip, hemi-, femoral, metal devices
- UHR UH1-48-28Howmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal2 recalls3 reports
- "UNITED" USTAR II Knee System 2515-3111United Orthopedic Corp. · Prosthesis, Hip, Hemi-, Femoral, Metal2 recalls0 reports
- "UNITED" USTAR II Knee System 2515-3213United Orthopedic Corp. · Prosthesis, Hip, Hemi-, Femoral, Metal2 recalls0 reports
- STAGEONE 431207Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal2 recalls0 reports
- "UNITED" USTAR II Knee System 2515-3115United Orthopedic Corp. · Prosthesis, Hip, Hemi-, Femoral, Metal2 recalls0 reports
- ACTIS 101011050Depuy (Ireland) · Prosthesis, hip, hemi-, femoral, metal73 reports
- UHR UH1-46-26Howmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal1 recall11 reports
- UHR UH1-45-26Howmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal1 recall11 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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