Taperloc Complete Primary Femoral 51-103110Recalls & 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
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00880304489745), received between Jun 26, 2020 and Jan 5, 2026 — classified as 1 injury, 9 malfunctions.
The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (4 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
- Device Contaminated During Manufacture or Shipping4
- Positioning Failure2
- Adverse Event Without Identified Device or Use Problem1
- Difficult to Insert1
- Inadequacy of Device Shape and/or Size1
- Tear, Rip or Hole in Device Packaging1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- No Patient Involvement3
- Ambulation or Postural Difficulties1
- Bone Fracture(s)1
- Pain1
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 5, 2026Positioning Failure
IT WAS REPORTED THAT DURING SURGERY, THE STEM DID NOT SINK FAR ENOUGH INTO THE FEMUR. THE STEM WAS NOT USED. 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 23955251 ↗InjuryDec 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY. DURING SURGERY, IT WAS FOUND THAT THE PATIENT¿S FEMUR WAS FRACTURED, CAUSING LOSS OF BLOOD. THE LOSS OF BLOOD CAUSED INSTABILITY IN THE PATIENT¿S BLOOD PRESSURE LEADING TO A LONGER STAY IN THE HOSPITAL. THE PATIENT EXPERIENCED PAIN WHILE HEALING AND EVEN WHEN WALKING, SITTING OR STANDING. THE PATIENT IS CONCERNED FOR THE FUTURE AND THE IMPLANT DUE TO ZIMMER BIOMET¿S RECALL.
Patient problems: Ambulation or Postural Difficulties; Bone Fracture(s); Pain
MAUDE report 20914158 ↗MalfunctionJul 3, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT THE FEMORAL STEM WAS NOT CORRELATING WITH BROACH SIZE. THE SURGEON BELIEVED IT WAS OVERSIZED FROM PLASMA SPRAY. 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 17248753 ↗MalfunctionJan 11, 2023Difficult to Insert; Difficult to Insert
IT WAS REPORTED THAT THE SURGEON HAD DIFFICULTY WITH THE STEM NOT SEATING TO THE EXACT BROACH SIZE. THE BROACHES WENT DOWN TO WHERE THEY WERE SUPPOSED TO; HOWEVER, THE IMPLANT SAT BETWEEN 1-4 MM PROUD. THE SURGEON WOULD THEN DROP DOWN 2-3 SIZES AND REBROACH. AFTER THAT, THE IMPLANT WOULD SIT IN PLACE. THERE WERE NO PATIENT COMPLICATIONS. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16136895 ↗MalfunctionOct 12, 2022Positioning Failure; Positioning Failure
IT WAS REPORTED THAT A STEM SAT PROUD DURING AN INITIAL PROCEDURE. THE SURGEON WENT DOWN ONE SIZE AND IT FIT. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES TO THE PATIENT. THERE WAS A 6 (SIX) MINUTE DELAY. 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 15590850 ↗MalfunctionMar 14, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
NO ADDITIONAL INFORMATION ON THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13757374 ↗MalfunctionJul 19, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12188114 ↗MalfunctionJan 27, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
Patient problems: No Patient Involvement
MAUDE report 11236114 ↗MalfunctionJun 26, 2020Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED UPON INSPECTION AT THE INCOMING WAREHOUSE, THERE WAS DEBRIS IN THE STERILE PACKAGE. NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Patient Involvement
MAUDE report 10201142 ↗MalfunctionJun 26, 2020Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Patient Involvement
MAUDE report 10201117 ↗
Other Prosthesis, hip, semi-constrained, metal/polymer, uncemented devices
- LFIT 6260-9-136Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, uncemented166 reports
- Trident 623-00-36EHowmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, uncemented112 reports
- Accolade 6021-0435Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, uncemented88 reports
- EXETER 0580-1-044Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, uncemented1 recall22 reports
- Endo-Model SL Knee Prosthesis System 16-2840/02WALDEMAR LINK GmbH & Co. KG · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented1 recall17 reports
- Endo-Model SL Knee Prosthesis System 16-2840/05WALDEMAR LINK GmbH & Co. KG · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented1 recall12 reports
- Trident 623-10-36EHowmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, uncemented57 reports
- LFIT 6260-9-336Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, uncemented56 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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