Taperloc Complete Primary Femoral 51-101070Recalls & 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 cemented artificial hip component. Reports mostly describe damaged sterile packaging found during stock checks, with the implant poking through the pouch and no patient involved. There are 24 reports that mention this identifier, with 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
- 23
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00880304489769), received between Jan 2, 2020 and Aug 31, 2026 — classified as 2 injuries, 21 malfunctions.
The most frequently reported specific device problem is “Packaging Problem” (9 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
- Packaging Problem9
- Tear, Rip or Hole in Device Packaging6
- Delivered as Unsterile Product2
- Difficult to Insert2
- Manufacturing, Packaging or Shipping Problem2
- Adverse Event Without Identified Device or Use Problem1
- Device Contaminated During Manufacture or Shipping1
- Migration1
Patient problems
- No Clinical Signs, Symptoms or Conditions20
- Bone Fracture(s)2
- Failure of Implant1
- No Patient Involvement1
- Pain1
Recent adverse event reports
The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 31, 2026Tear, Rip or Hole in Device Packaging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50529501 ↗MalfunctionMar 31, 2026Tear, 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 24746143 ↗MalfunctionOct 28, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT THE TAPERLOC IMPLANTS WERE POKING THROUGH THE PACKAGING. NO PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION AVAILABLE FOR THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23406421 ↗MalfunctionOct 28, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT THE TAPERLOC IMPLANTS WERE POKING THROUGH THE PACKAGING. NO PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION AVAILABLE FOR THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23406415 ↗MalfunctionAug 11, 2025Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT DURING STOCK INSPECTION; THE INNER PACKAGING WAS FOUND BREACHED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22778714 ↗MalfunctionJul 14, 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 22503408 ↗MalfunctionMar 12, 2025Packaging Problem; Packaging Problem
IT WAS REPORTED THAT THE CIRCULATED ITEMS WERE INSPECTED, AND THE STERILE PACKAGING WAS DETERMINED 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 21584449 ↗MalfunctionFeb 24, 2025Difficult to Insert; Difficult to Insert
IT WAS REPORTED THAT DURING A PROCEDURE, THE STEM SAT PROUD 2 CM. THE DOCTOR REMOVED THAT STEM AND IMPLANTED A NEW ONE THAT ALSO SAT .5CM PROUD. BROACHING WAS COMPLETED USING THE SAME SIZE AS THE IMPLANT. THE SECOND STEM WAS USED TO 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 21447094 ↗MalfunctionJan 2, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT WHEN OPENING THE PACKAGING OF THE IMPLANT FOR THE PROCEDURE, IT STERILE PACKAGING WAS FOUND TO BE DAMAGED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO HARM OR HEALTH CONSEQUENCES TO THE PATIENT. IT WAS REPORTED THAT NO ADDITIONAL INFORMATION ON THE REPORTED EVENT IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21056467 ↗InjuryJul 25, 2024Noise, Audible; Migration; Noise, Audible; Migration
IT WAS REPORTED THAT THE PATIENT REPORTED UNUSUAL NOISE AND DISCOMFORT DURING REHABILITATION. X-RAYS WERE PERFORMED AND CONFIRMED STEM SUBSIDENCE AND ASSOCIATED SUB-TROCHANTERIC FRACTURE. SUBSEQUENTLY, A REVISION WAS COMPLETED FOURTEEN DAYS POST IMPLANTATION OF A TOTAL HIP ARTHROPLASTY. NO ADDITIONAL INFORMATION WAS RECEIVED.
Patient problems: Bone Fracture(s); Failure of Implant; Pain
MAUDE report 19828619 ↗MalfunctionJul 8, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT THERE WAS A HOLE IN THE PACKAGING. 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 19690461 ↗MalfunctionNov 9, 2023Packaging Problem; Packaging Problem
THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18104109 ↗MalfunctionMar 8, 2023Difficult to Insert; Difficult to Insert
IT WAS REPORTED THAT SURGEON BROACHED WITH A TAPERLOC SIZE 7 BROACH ON THE PATIENT'S LEFT SIDE. THE CORRESPONDING SIZE 7 TAPERLOC STEM IMPLANT DID NOT GO DOWN TO THE LEVEL THAT WAS BROACHED. THE STEM WAS REMOVED, AND ANOTHER STEM WAS USED. THERE WERE NO SURGICAL COMPLICATIONS. NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16504709 ↗MalfunctionNov 29, 2022Packaging Problem; Packaging Problem
IT WAS REPORTED THAT DURING WAREHOUSE INSPECTION, THE STERILE PACKAGE WAS FOUND TO BE DAMAGED. IT IS UNKNOWN IF THERE WAS A BREECH IN STERILITY. 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 15876006 ↗MalfunctionNov 29, 2022Packaging Problem; Packaging Problem
IT WAS REPORTED THAT DURING WAREHOUSE INSPECTION, THE STERILE PACKAGE WAS FOUND TO BE DAMAGED. IT IS UNKNOWN IF THERE WAS A BREECH IN STERILITY. 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 15876005 ↗MalfunctionSep 26, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT DURING INSPECTION AT THE WAREHOUSE, THE INNER POUCH WAS FOUND TO BE TORN. 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 15487018 ↗InjurySep 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING A HIP PROCEDURE, THE PATIENTS FEMUR FRACTURED WHILE ATTEMPTING TO IMPLANT THE STEM. THE SURGEON USED A MICRO STEM AND PLACED CABLES TO COMPLETE THE SURGERY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Bone Fracture(s)
MAUDE report 15471637 ↗MalfunctionAug 22, 2022Packaging Problem; Packaging Problem
IT WAS REPORTED THAT THE PLASTIC CONTAINER CONTAINED BURN HOLES ON IT CAUSING STERILITY QUESTIONS. THERE WAS NO IMPACT OR HARM TO THE 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 15264089 ↗MalfunctionMar 19, 2022Packaging Problem; Packaging Problem
IT WAS REPORTED DURING THE INCOMING INSPECTION AT (B)(6) WAREHOUSE IN (B)(6). A TEAM MEMBER FOUND DEBRIS IN THE STERILE PACKAGE. NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13825371 ↗MalfunctionFeb 24, 2022Device Contaminated During Manufacture or Shipping; Packaging Problem; Device Contaminated During Manufacture or Shipping; Packaging Problem
IT WAS REPORTED THAT AN IMPLANT WAS FOUND PROTRUDING FROM THE STERILE PACKAGING AND DEBRIS WAS FOUND. A NEW IMPLANT WAS USED TO COMPLETE THE SURGERY. THERE WAS NO REPORTED HARM OR INJURY TO THE 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 13594000 ↗MalfunctionAug 4, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT THE OUTER BOX WAS OPENED AND IT WAS IMMEDIATELY OBSERVED THAT THE STEM INSIDE HAD PENETRATED THE STERILE PLASTIC CONTAINER. A BACK UP WAS AVAILABLE TO COMPLETE THE PROCEDURE WITHOUT DELAY. NO PATIENTS INVOLVED. 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 12275986 ↗MalfunctionMar 12, 2021Packaging Problem; Packaging Problem
IT WAS REPORTED THE REPRESENTATIVE INVESTIGATED CIRCULATED ITEMS AND IDENTIFIED STERILE PACKAGE DAMAGE. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11472284 ↗MalfunctionJan 2, 2020Packaging Problem; Packaging Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Patient Involvement
MAUDE report 9539517 ↗
Other Prosthesis, hip, semi-constrained, metal/polymer, cemented devices
- NA 1365-51-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented753 reports
- NA 1365-50-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented412 reports
- ARTICUL/EZE 1365-21-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 recall280 reports
- ARTICUL/EZE 1365-11-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 death262 reports
- LFIT 6260-9-236Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, cemented256 reports
- PINNACLE GRIPTION 1217-32-052Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented2 deaths239 reports
- ELEOS™ 25002111EOnkos Surgical, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented3 deaths230 reports
- Novation 130-36-52Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2 recalls124 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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