BIOLOX OptionRecalls & reported problems across all models
Biomet Uk Ltd · 5 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
2 open recalls name at least one BIOLOX Option model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 45
- Deaths reported
- 0
- Injuries reported
- 38
- Recalls
- 2
We found 5 models of BIOLOX Option by Biomet Uk Ltd in the FDA's device registry (GUDID). Together they are named in 45 adverse event reports in the FDA's MAUDE database, received between Apr 8, 2020 and Aug 10, 2026 — classified as 38 injuries, 7 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (8 reports).
2 FDA recall records name at least one of these models by its device identifier, 2 still open.
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
BIOLOX Option 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.
- Aug 8, 2024Class IIOpen, Classified
Mislabeled: Incorrect sleeve in the packaging. The outer packaging is labeled as a standard neck sleeve, however, the product within the box is a -6mm neck sleeve, and vice versa. The neck of the sleeve can be identified by the device etching as either STD or -6
Z-3133-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Aug 8, 2024Class IIOpen, Classified
Mislabeled: Incorrect sleeve in the packaging. The outer packaging is labeled as a standard neck sleeve, however, the product within the box is a -6mm neck sleeve, and vice versa. The neck of the sleeve can be identified by the device etching as either STD or -6
Z-3132-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported BIOLOX Option problems
Device problems
- Adverse Event Without Identified Device or Use Problem29
- Device Dislodged or Dislocated8
- Activation, Positioning or Separation Problem2
- Component or Accessory Incompatibility2
- Difficult to Insert2
- Positioning Problem2
- Unintended Movement2
- Collapse1
Patient problems
- Pain12
- Joint Dislocation7
- Failure of Implant6
- No Clinical Signs, Symptoms or Conditions6
- Insufficient Information5
- Ambulation or Postural Difficulties4
- Unspecified Infection4
- Bacterial Infection3
BIOLOX Option models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- BIOLOX® Option 650-1066PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 recall12 reports
- BIOLOX® Option 650-1064PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 recall7 reports
- BIOLOX® Option 650-1068PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED12 reports
- BIOLOX® Option 650-1065PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED10 reports
- BIOLOX® Option 650-1067PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED4 reports
Recent BIOLOX Option adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
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 50190644 ↗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 23872268 ↗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 23013651 ↗InjuryAug 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, POST-IMPLANTATION, THE PATIENT ALLEGED EXPERIENCING MULTIPLE ISSUES, INCLUDING: EXCRUCIATING PAIN IMMEDIATELY AFTER SURGERY; A METALLIC TASTE IN THE MOUTH (WITH A CORRESPONDING NICKEL ALLERGY); A RASH ON THE LEG; SENSATIONS OF FEMORAL SHIFTING; TWO ROUNDS OF ANTIBIOTIC TREATMENT PLUS IV ANTIBIOTICS FOR INFECTION; LIMITED MOBILITY; NUMBNESS IN THE TOES WHEN LYING ON THE SIDE; HEART ATTACK¿LIKE SYMPTOMS; BACK PAIN; POTASSIUM AND MAGNESIUM INFUSIONS FOR AN UNKNOWN REASON, WHICH REPORTEDLY MADE THEM FEEL WORSE; ALLEGED PASSAGE OF A 5 MM PIECE OF METAL IN THE URINE (WHICH THE SURGEON STATED WAS MOST LIKELY A KIDNEY STONE); AND OTHER GREEN PARTICLES IN THE URINE, SUSPECTED TO BE SUTURE MATERIAL. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NO FURTHER DETAILS HAVE BEEN PROVIDED.
Patient problems: Ambulation or Postural Difficulties; Hypersensitivity/Allergic reaction; Pain; Rash; Unspecified Infection
MAUDE report 22837756 ↗InjuryJun 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED IN A CLINICAL STUDY THAT APPROXIMATELY TWO YEARS POST-IMPLANTATION, THE PATIENT UNDERWENT A HIP REVISION DUE TO SEVERE PAIN AND FAILED IMPLANTS. PATIENT EXPERIENCED PAIN, WEAKNESS, TROCHANTERIC BURSITIS, AND POSSIBLE ILIOPSOAS TENDINITIS. THE SHELL WAS RETAINED AND ALL OTHER IMPLANTS REVISED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Bursitis; Failure of Implant; Inflammation; Muscle Weakness/Atrophy; Pain
MAUDE report 22182204 ↗MalfunctionMar 13, 2025Difficult to Insert; Separation Failure; Difficult to Insert; Separation Failure
IT WAS REPORTED THAT DURING THE SURGERY ADAPTER MAY HAVE NOT SEATED CORRECTLY ON THE STEM, WHICH CAUSED THE HEAD TO POTENTIALLY SIT HIGHER THAN IT SHOULD HAVE. THE SURGEON TRIED TO SEPARATE THE HEAD/TAPER FROM THE STEM, BUT THE TAPER REMAINED ON THE STEM WHILE THE HEAD SEPARATED FROM THE TAPER. HE HAD TO REPLACE THAT STEM WITH A NEW STEM AS THE TAPER WOULD NOT DISENGAGE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21593579 ↗InjuryFeb 12, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant
MAUDE report 21364062 ↗InjuryNov 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
Patient problems: Insufficient Information
MAUDE report 20785599 ↗InjuryOct 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED PATIENT UNDERWENT HIP REVISION FOR UNKNOWN REASONS; THE SURGEON EXPLANTED FEMORAL HEAD AND ACETABULAR COMPONENTS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Insufficient Information
MAUDE report 20544931 ↗MalfunctionOct 17, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT DUE TO A LABELING ISSUE A WRONG ITEM IN BOX WAS RECEIVED AND LATER IMPLANTED. THE SURGEON STATED THAT THEY IMPLANTED WHAT THEY THOUGHT WAS A STANDARD 0MM AS STANDS IN PACKAGE, BUT IT LOOKS FROM POST-OP X-RAY THAT A 6MM WAS IMPLANTED INSTEAD. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20470801 ↗InjuryMay 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT APPROXIMATELY NINE YEARS AND SIX MONTHS POST IMPLANTATION, THE PATIENT WAS REVISED FOR LEG LENGTH DISCREPANCY. IT WAS INDICATED THAT THE PATIENT REQUIRED LONGER HEAD LENGTH. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Unequal Limb Length
MAUDE report 19257901 ↗InjuryApr 16, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT TWO YEARS AND FIVE MONTHS POST INITIAL OPERATION, THE PATIENT UNDERWENT A REVISION DUE TO A HIP DISLOCATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Joint Dislocation
MAUDE report 19114936 ↗InjuryMar 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ELEVEN DAYS AFTER A LEFT HIP PROCEDURE, THE PATIENT UNDERWENT A REVISION DUE TO PAIN AND CUP INSTABILITY. THE CUP INSTABILITY WAS ATTRIBUTED TO PATIENT POOR BONE QUALITY. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information; Pain
MAUDE report 18999451 ↗InjuryMar 11, 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 HIP REVISION APPROXIMATELY ONE YEAR AND SIX MONTHS POST IMPLANTATION DUE TO THIGH PAIN. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Pain
MAUDE report 18873296 ↗InjuryMar 11, 2024Adverse 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: Insufficient Information; Unequal Limb Length
MAUDE report 18873113 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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