Biomet Hip SystemRecalls & reported problems across all models
Biomet Orthopedics, LLC · 37 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 115
- Deaths reported
- 5
- Injuries reported
- 105
- Recalls
- 1
We found 37 models of Biomet Hip System by Biomet Orthopedics, LLC in the FDA's device registry (GUDID). Together they are named in 115 adverse event reports in the FDA's MAUDE database, received between Jan 12, 2016 and Sep 15, 2026 — classified as 5 deaths, 105 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (62 reports).
1 FDA recall record name at least one of these models by its device identifier.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Biomet Hip System recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Sep 15, 2017Terminated
One piece from a different lot mixed with lot 236840 and is incorrectly etched as -6MM offset instead of +3MM offset. As the incorrect etching and related size difference affects the functional use of this product, the affected lot is being removed from the field.
Z-1008-2018 · Root cause: Error in labeling · Recall details · FDA record ↗
Most reported Biomet Hip System problems
Device problems
- Device Dislodged or Dislocated62
- Adverse Event Without Identified Device or Use Problem24
- Detachment of Device or Device Component12
- Material Erosion6
- Unstable4
- Difficult to Insert3
- Activation, Positioning or Separation Problem1
- Corroded1
Patient problems
- Joint Dislocation64
- Pain25
- Failure of Implant14
- Ambulation or Postural Difficulties9
- Fall8
- Metal Related Pathology8
- Insufficient Information6
- Subluxation6
Biomet Hip System models
37 models, most reported first. Each model has its own page with its reports, recalls and device details.
- BIOMET HIP SYSTEM 11-363660PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 recall2 reports
- Biomet® Hip System 163662PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER4 deaths17 reports
- Biomet® Hip System 163661Prosthesis, hip, semi-constrained, metal/polymer, cemented12 reports
- BIOMET HIP SYSTEM 163668Prosthesis, hip, semi-constrained, metal/polymer, cemented6 reports
- Biomet® Hip System 11-363662PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED6 reports
- Biomet® Hip System 163669Prosthesis, hip, semi-constrained, metal/polymer, cemented6 reports
- Biomet® Hip System 163638Prosthesis, hip, semi-constrained, metal/polymer, cemented5 reports
- Biomet® Hip System 163668Prosthesis, hip, femoral component, cemented, metal5 reports
- BIOMET HIP SYSTEM 11-363665PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED4 reports
- BIOMET HIP SYSTEM 163660Prosthesis, hip, semi-constrained, metal/polymer, cemented4 reports
- Biomet® Hip System 11-363660Prosthesis, hip, semi-constrained, metal/polymer, cemented4 reports
- Biomet® Hip System 11-363661Prosthesis, hip, semi-constrained, metal/polymer, cemented4 reports
- Biomet® Hip System 163660Prosthesis, hip, femoral component, cemented, metal4 reports
- BIOMET HIP SYSTEM 11-363663PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED3 reports
- Biomet® Hip System 163663PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED3 reports
- Biomet® Hip System 163667Prosthesis, hip, semi-constrained, metal/polymer, cemented3 reports
- BIOMET HIP SYSTEM 163663Prosthesis, hip, semi-constrained, metal/polymer, cemented3 reports
- BIOMET HIP SYSTEM 163674Prosthesis, hip, semi-constrained, metal/polymer, cemented2 reports
- BIOMET HIP SYSTEM 163670Prosthesis, hip, semi-constrained, metal/polymer, cemented2 reports
- Biomet® Hip System 163670Prosthesis, hip, semi-constrained, metal/polymer, cemented2 reports
- BIOMET HIP SYSTEM 163669Prosthesis, hip, semi-constrained, metal/polymer, cemented2 reports
- BIOMET HIP SYSTEM 11-363661PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- BIOMET HIP SYSTEM 11-363662PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- BIOMET HIP SYSTEM 163651Prosthesis, hip, semi-constrained, composite/metal1 report
- BIOMET HIP SYSTEM 163652Prosthesis, hip, semi-constrained, composite/metal1 report
- BIOMET HIP SYSTEM 163661Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- BIOMET HIP SYSTEM 163672Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- Biomet® Hip System 11-363663PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- Biomet® Hip System 11-363663Prosthesis, hip, semi-constrained, metal/polymer, cemented1 death1 report
- Biomet® Hip System 11-363665PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- Biomet® Hip System 163652PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- Biomet® Hip System 163665PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- Biomet® Hip System 163666Prosthesis, hip, femoral component, cemented, metal1 report
- Biomet® Hip System 163672Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- Biomet® Hip System 163674PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- BIOMET HIP SYSTEM 163665Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- BIOMET HIP SYSTEM 163666Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
Recent Biomet Hip System adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 15, 2026Device Dislodged or Dislocated
It was reported that the patient underwent an initial hip procedure. Subsequently, the patient was revised due to dislocation approximately 12 weeks after. Attempts have been made and no further information has been provided.
Patient problems: Joint Dislocation
MAUDE report 50777887 ↗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 23, 2026Unstable
IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIP REVISION APPROXIMATELY 1 YEAR POST IMPLANTATION DUE TO INSTABILITY. DURING THE PROCEDURE, THE LINER AND HEAD WERE REVISED. IT WAS CONFIRMED THAT NO FURTHER INFORMATION COULD BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25595454 ↗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 ↗InjuryMay 21, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT ONE DAY POST HIP REVISION, THE PATIENT UNDERWENT A HIP REVISION DUE TO A DISLOCATION. THE PROXIMAL BODY AND DISTAL STEM WERE FOUND TO BE LOOSE AND NOT MATED PROPERLY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Joint Dislocation
MAUDE report 25244603 ↗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 ↗InjuryMar 11, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT APPROXIMATELY TWO AND A HALF YEARS POST-IMPLANTATION, THE PATIENT UNDERWENT A LEFT HIP REVISION DUE TO INSTABILITY AND RECURRENT DISLOCATION. ALL COMPONENTS REVISED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Joint Dislocation; Joint Laxity
MAUDE report 24568119 ↗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 ↗InjuryFeb 9, 2026Patient-Device Incompatibility
IT WAS REPORTED THAT APPROXIMATELY TWO YEARS POST-IMPLANTATION, THE PATIENT UNDERWENT A HIP REVISION DUE TO INSTABILITY, LOOSENING, AND A POSSIBLE METAL ALLERGY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Aseptic loosening; Hypersensitivity/Allergic reaction; Joint Laxity
MAUDE report 24298579 ↗InjuryJan 12, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT APPROXIMATELY SIX WEEKS POST-IMPLANTATION, THE PATIENT UNDERWENT A CLOSED REDUCTION DUE HIP DISLOCATION. THE PATIENT SUFFERED TWO PREVIOUS DISLOCATIONS AND THE LATEST OCCURRED WHEN THEY WERE LYING IN BED AND TURNED ONTO THEIR HIP. THE HIP WAS REDUCED UNDER GENERAL ANESTHESIA WITHOUT DIFFICULTY. FOLLOWING THE PROCEDURE, WHEN PERFORMING TRACTIONS, THERE WAS SOME SUBLUXATION, SO THE HIP WAS IMMOBILIZED TO NOT FLEX THE HIP. THE FOLLOWING DAY, IT WAS RE-EVALUATED AND THE THIGH WAS LIFTED WITHOUT PROBLEM OR PAIN. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Joint Dislocation
MAUDE report 24032912 ↗InjuryDec 17, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.
Patient problems: Joint Dislocation
MAUDE report 23827981 ↗InjuryDec 16, 2025Material Erosion; Material Erosion
NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Ambulation or Postural Difficulties; High metal ion levels; Metal Related Pathology; Muscle/Tendon Damage; Necrosis; Pain
MAUDE report 23821054 ↗InjuryNov 19, 2025Unstable; Unstable
NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.
Patient problems: Joint Laxity
MAUDE report 23594765 ↗
Other Biomet Orthopedics, LLC products
- AFFIXUSHIP FRACTURE NAIL - RIGHT39 models · 6 reports · 37 recalls
- AFFIXUSHIP FRACTURE NAIL - LEFT27 models · 7 reports · 24 recalls
- Compress Device71 models · 99 reports · 22 recalls
- Arcos Modular Revision Hip System71 models · 191 reports · 19 recalls
- Comprehensive Reverse Shoulder57 models · 895 reports · 3 recalls
- Vanguard Knee System147 models · 306 reports · 13 recalls
- STAGEONE17 models · 0 reports · 18 recalls
- StageOne Select15 models · 2 reports · 15 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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