BIOLOX delta OptionRecalls & reported problems across all models
Biomet Uk Ltd · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 89
- Deaths reported
- 0
- Injuries reported
- 79
- Recalls
- 0
We found 4 models of BIOLOX delta Option by Biomet Uk Ltd in the FDA's device registry (GUDID). Together they are named in 89 adverse event reports in the FDA's MAUDE database, received between Apr 8, 2020 and Aug 10, 2026 — classified as 79 injuries, 10 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (31 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. 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
Most reported BIOLOX delta Option problems
Device problems
- Adverse Event Without Identified Device or Use Problem37
- Device Dislodged or Dislocated31
- Fracture6
- Unintended Movement6
- Mechanical Problem5
- Patient Device Interaction Problem4
- Activation, Positioning or Separation Problem3
- Detachment of Device or Device Component3
Patient problems
- Joint Dislocation31
- Pain22
- Failure of Implant17
- Insufficient Information10
- No Clinical Signs, Symptoms or Conditions10
- Ambulation or Postural Difficulties7
- Fall5
- Bacterial Infection4
BIOLOX delta Option models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- BIOLOX® delta Option 650-1055PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED41 reports
- BIOLOX® delta Option 650-1057PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED25 reports
- BIOLOX® delta Option 650-1058PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED17 reports
- BIOLOX® delta Option 650-1056PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED6 reports
Recent BIOLOX delta Option adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 10, 2026Fracture
It was reported that the ceramic head fractured upon impact during the procedure. The surgeon completed the surgery using an alternative device. The fractured ceramic head did not come into contact with the patient, and no fragments remained in the patient. There was no serious injury to the patient and no delay in the procedure. Attempts have been made and no further information has been provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50190710 ↗InjuryAug 10, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient reported ongoing extreme pain and swelling after the revision. Attempts have been made, and no further information has been provided.
Patient problems: Pain; Swelling/ Edema
MAUDE report 50190642 ↗InjuryJun 1, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT APPROXIMATELY ONE YEAR AND FOUR MONTHS AGO, THE PATIENT UNDERWENT A LEFT HIP REVISION SURGERY DUE TO JOINT DISLOCATION. SINCE THAT PROCEDURE, THE PATIENT HAS EXPERIENCED RECURRENT LEFT HIP DISLOCATIONS. THE PATIENT IS NOW BEING CONSIDERED FOR A NEW PMI CUSTOM CONSTRAINED LINER TO ADDRESS THE ONGOING INSTABILITY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Joint Dislocation
MAUDE report 25347010 ↗MalfunctionApr 30, 2026Device Markings/Labelling Problem
IT WAS REPORTED THAT DURING A HIP REVISION PROCEDURE, THE STERILE PACKAGE LABELED FOR A 32 MM MODULAR CERAMIC HEAD WITH AN OPTION SLEEVE (+6) WAS OPENED AND THE MISMATCH BETWEEN THE LABELED CONTENTS AND THE ACTUAL DEVICE WAS IDENTIFIED. THE PACKAGE CONTAINED A NONMODULAR 32 MM CERAMIC HEAD (-3). OBTAINING A CORRECT REPLACEMENT CAUSED A DELAY OF APPROXIMATELY 15 MINUTES. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25039465 ↗InjuryMar 2, 2026Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Ambulation or Postural Difficulties; Pain
MAUDE report 24481793 ↗InjuryFeb 2, 2026Fracture; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION SURGERY DUE TO UNKNOWN REASONS. HOWEVER, DURING THE REVISION SURGERY, THE CERAMIC FEMORAL HEAD FRACTURED WHILE THE SURGEON WAS ATTEMPTING TO REMOVE THE TAPER SLEEVE FROM THE CERAMIC HEAD BY TAPPING IT WITH A MALLET. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.
Patient problems: Insufficient Information
MAUDE report 24233270 ↗InjuryJan 15, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT UNDERWENT HIP REVISION SURGERY DUE TO HEAD DISLOCATION. DURING THE REVISION, ONLY THE REMOVED DELTA CERAMIC HEAD SHOWED SIGNIFICANT DAMAGE, APPROXIMATELY 2 YEARS, 9 MONTHS, AND 9 DAYS POST-IMPLANTATION. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Joint Dislocation
MAUDE report 24077741 ↗InjuryJan 12, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIP REVISION APPROXIMATELY ONE YEAR AND EIGHT MONTHS POST-IMPLANTATION DUE TO DISSOCIATION OF THE FEMORAL HEAD AND BEARING. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Joint Dislocation
MAUDE report 24033893 ↗InjuryDec 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Bradycardia; Hematoma; Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension
MAUDE report 23872298 ↗InjuryDec 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL EVENT INFORMATION.
Patient problems: Hematoma; Pain; Post Operative Wound Infection
MAUDE report 23756438 ↗InjuryNov 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Joint Dislocation
MAUDE report 23579374 ↗InjuryNov 10, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Joint Dislocation; Pain
MAUDE report 23508746 ↗InjuryNov 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Purulent Discharge; Swelling/ Edema; Wound Dehiscence
MAUDE report 23483962 ↗InjurySep 10, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Joint Dislocation; Joint Impingement; Joint Laxity; Pain
MAUDE report 23013655 ↗InjurySep 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Joint Laxity; Medical device site infection; Periprosthetic fracture
MAUDE report 23013649 ↗
Other Biomet Uk Ltd products
All Biomet Uk Ltd devices →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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