Biomet® Hip System 163662Recalls & reported problems
Biomet Orthopedics, LLC · Class 2 · Implant
All models of Biomet Hip System (37)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 17
- Deaths reported
- 4
- Injuries reported
- 13
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00887868308277), received between Jun 24, 2020 and Aug 24, 2026 — classified as 4 deaths, 13 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (6 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
- Adverse Event Without Identified Device or Use Problem6
- Device Dislodged or Dislocated6
- Detachment of Device or Device Component5
- Unstable1
Patient problems
- Joint Dislocation6
- Failure of Implant3
- Fall2
- Insufficient Information2
- No Code Available2
- Unspecified Infection2
- Cardiac Arrest1
- Stroke/CVA1
Recent adverse event reports
The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.
InjuryAug 24, 2026Device Dislodged or Dislocated
It was reported that the patient underwent an initial hip procedure. The patient underwent a revision approximately 2 months later due to dislocation following a fall. The Bipolar was revised. Attempts have been made and no further information has been provided.
Patient problems: Joint Dislocation
MAUDE report 50407636 ↗InjuryJun 2, 2026Unstable
IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIP REVISION APPROXIMATELY ONE MONTH POST IMPLANTATION DUE TO INSTABILITY AND LEG LENGTH DISCREPANCIES. DURING THE PROCEDURE, IT WAS NOTED THAT A DECISION WAS MADE TO REMOVE THE RESURFACING CUP AND REPLACE WITH A G7 DUAL MOBILITY. THE TAPERLOC STEM WAS LEFT IN SITU AND THE 28MM T1 TAPER HEAD AND DM BEARING REMOVED. CUP WAS REPLACED AND NEW 28MM AND DM BEARING WAS INSERTED. DUE DILIGENCE IS COMPLETE AS MULTIPLE ATTEMPTS WERE MADE; HOWEVER, NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Unequal Limb Length
MAUDE report 25359645 ↗DeathMar 23, 2026Adverse Event Without Identified Device or Use Problem
NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Stroke/CVA
MAUDE report 24664455 ↗DeathMar 23, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT APPROXIMATELY FIVE WEEKS POST RIGHT HIP IMPLANTATION, THE PATIENT PASSED AWAY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Insufficient Information
MAUDE report 24662489 ↗DeathMar 23, 2026Adverse Event Without Identified Device or Use Problem
NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Cardiac Arrest
MAUDE report 24662329 ↗DeathMar 6, 2026Adverse Event Without Identified Device or Use Problem
NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24530385 ↗InjuryOct 6, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
DUE DILIGENCE IS COMPLETE AS MULTIPLE ATTEMPTS WERE MADE; HOWEVER, NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Fall; Joint Dislocation
MAUDE report 23223358 ↗InjuryMar 12, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT APPROXIMATELY TWO WEEKS POST-IMPLANTATION, THE PATIENT UNDERWENT A HIP REVISION DUE TO THE HEAD COMING OFF THE STEM. ALL IMPLANTS WERE REPLACED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Failure of Implant
MAUDE report 21583750 ↗InjuryJan 22, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO DISLOCATION AT THE SITE. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Joint Dislocation
MAUDE report 21211256 ↗InjuryJul 18, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
Patient problems: Joint Dislocation
MAUDE report 19774233 ↗InjuryJul 5, 2024Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
Patient problems: Failure of Implant; Joint Dislocation
MAUDE report 19680383 ↗InjuryMay 31, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE 29 DAYS POST IMPLANTATION DUE TO A DISLOCATION. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Joint Dislocation
MAUDE report 19434479 ↗InjuryNov 6, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.
Patient problems: Failure of Implant
MAUDE report 18074778 ↗InjuryMar 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.
Patient problems: Unspecified Infection
MAUDE report 11515629 ↗InjuryMar 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE RECEIVED ADDITIONAL INFORMATION DOES NOT CHANGE THE FINAL CONCLUSIONS OF PREVIOUS INVESTIGATION.
Patient problems: Unspecified Infection
MAUDE report 11515618 ↗InjuryJul 8, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Code Available
MAUDE report 10244722 ↗InjuryJun 24, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT A PATIENT UNDERWENT BILATERAL DUAL MOBILITY HIP REPLACEMENT. THE PATIENT FELL IN THE SHOWER SIXTEEN DAYS LATER AND DISLOCATED THE RIGHT HIP, DUAL MOBILITY HEAD AND BEARING STILL INTACT. UPON REDUCTION IN THE ER, THE BEARING CAME DISASSOCIATED FROM THE HEAD. THE 28 MM HEAD WAS STILL ON THE STEM AND WAS REDUCED INTO THE G7 CUP, BUT THE DM POLY BEARING WAS FLOATING LOOSELY IN THE CAPSULE. THE PATIENT HAD REVISION SURGERY TWENTY DAYS AFTER THE INITIAL SURGERY. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Fall; No Code Available
MAUDE report 10188246 ↗
Other PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER devices
- ELEOS™ 25001208EOnkos Surgical, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER3 deaths193 reports
- ELEOS™ THSMWRS01MOnkos Surgical, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER190 reports
- "UNITED" USTAR II Hip System 1115-1413United Orthopedic Corp. · Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer3 recalls3 reports
- "UNITED" USTAR II Hip System 1115-1213United Orthopedic Corp. · Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer3 recalls0 reports
- "UNITED" USTAR II Hip System 1115-1417United Orthopedic Corp. · Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer3 recalls0 reports
- "UNITED" USTAR II Hip System 1115-1217United Orthopedic Corp. · Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer3 recalls0 reports
- Endo-Model Modular Knee Prosthesis System 15-3816/12WALDEMAR LINK GmbH & Co. KG · Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer2 recalls6 reports
- Endo-Model Modular Knee Prosthesis System 15-3816/11WALDEMAR LINK GmbH & Co. KG · Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer2 recalls6 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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