TAPERLOC COMPLETE INSTRUMENT 51-222224Recalls & reported problems
Biomet Orthopedics, LLC · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 12
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00880304509719), received between Sep 9, 2021 and Mar 12, 2026 — classified as 12 malfunctions.
The most frequently reported specific device problem is “Fracture” (12 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
- Fracture12
Patient problems
- No Clinical Signs, Symptoms or Conditions12
Recent adverse event reports
The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 12, 2026Fracture
IT WAS REPORTED THAT THE INSERTER BROKE WHILE THE SURGEON WAS IMPLANTED THE STEM. ANOTHER INSERTER WAS USED TO SUCCESSFULLY COMPLETE THE CASE. THERE WERE NO PATIENT CONSEQUENCES OR IMPACT. IT WAS CONFIRMED THAT NO FURTHER INFORMATION COULD BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24583265 ↗MalfunctionMar 4, 2024Fracture; Fracture
IT WAS REPORTED THAT THE STEM INSERTER TIP BROKE DURING USE. THERE WAS NO KNOWN IMPACT OR CONSEQUENCES TO THE PATIENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18827657 ↗MalfunctionJan 30, 2024Fracture; Fracture
IT WAS REPORTED THAT WHILE THE SURGEON WAS IMPACTING THE STEM, THE TIP OF THE INSERTER FRACTURED OFF INTO THE STEM. THE DOCTOR WAS ABLE TO REMOVE THE TIP FROM THE STEM AND SURGERY WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT INJURY AS A RESULT OF THE MALFUNCTION. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18607384 ↗MalfunctionNov 29, 2023Fracture; Fracture
DURING IMPACTION OF THE FEMORAL COMPONENT, THE INSERTER BROKE. 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 18226808 ↗MalfunctionOct 25, 2023Fracture; Fracture
NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18003541 ↗MalfunctionJul 3, 2023Fracture; Fracture
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17252650 ↗MalfunctionFeb 27, 2023Fracture; Fracture
THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16446271 ↗MalfunctionFeb 9, 2023Fracture; Fracture
THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16343001 ↗MalfunctionOct 5, 2022Fracture; Fracture
IT WAS REPORTED HE OFFSET TAPERLOC STEM IMPACTOR BROKE DURING FEMORAL STEM IMPACTION. NO ADDITIONAL INFORMATION AVAILABLE ON THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15542937 ↗MalfunctionJul 12, 2022Fracture; Fracture
IT WAS REPORTED DURING IMPLANTATION THE TIP OF THE TAPERLOC BROKE. 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 14984960 ↗MalfunctionDec 2, 2021Fracture; Fracture
IT WAS REPORTED AS THE SURGEON WENT TO USE THE THE FEMORAL IMPACTOR HE NOTICED IT WAS CRACKED. AS HE TOUCHED THE TIP OF THE IMPACTOR, IT FELL OFF. 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 12917719 ↗MalfunctionSep 9, 2021Fracture; Fracture
IT WAS REPORTED AS THE SURGEON WENT TO USE THE FEMORAL IMPACTOR HE NOTICED IT WAS CRACKED. AS HE TOUCHED THE TIP OF THE IMPACTOR, IT FELL OFF. 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 12447575 ↗
Other Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented devices
- BIOLOX DELTA 1365-32-310Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented551 reports
- PINNACLE ALTRX 1221-36-052Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented481 reports
- BIOLOX DELTA 1365-32-320Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 death314 reports
- BIOLOX DELTA 1365-36-720Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 death189 reports
- DJO SURGICAL 400-03-362Encore Medical, L.P. · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented187 reports
- Anthology 71365705Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented176 reports
- BIOLOX DELTA 1365-40-710Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented170 reports
- PINNACLE GRIPTION 1217-32-054Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented169 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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