Biolox OptionRecalls & reported problems across all models
Zimmer GmbH · 16 models in the FDA device registry
Data updated Oct 16, 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
- 68
- Deaths reported
- 0
- Injuries reported
- 68
- Recalls
- 2
We found 16 models of Biolox Option by Zimmer GmbH in the FDA's device registry (GUDID). Together they are named in 68 adverse event reports in the FDA's MAUDE database, received between Mar 2, 2018 and Sep 29, 2026 — classified as 68 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (37 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.
- Nov 2, 2023Class IIOpen, Classified
One product complaint was received reporting that there was an incorrect adapter in the packaging. An adapter with neck length M/+0 was inside the product packaging, which should have contained an adapter with neck length S/-3.0. The difference in neck length may be recognized by the size (S or M) indicator on the device.
Z-0570-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Nov 2, 2023Class IIOpen, Classified
One product complaint was received reporting that there was an incorrect adapter in the packaging. An adapter with neck length M/+0 was inside the product packaging, which should have contained an adapter with neck length S/-3.0. The difference in neck length may be recognized by the size (S or M) indicator on the device.
Z-0569-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported Biolox Option problems
Device problems
- Device Dislodged or Dislocated37
- Adverse Event Without Identified Device or Use Problem9
- Insufficient Device Problem Information9
- Appropriate Device Problem Term/Code Not Available8
- Patient Device Interaction Problem4
- Fracture3
- Patient-Device Incompatibility2
- Unintended Movement2
Patient problems
- Joint Dislocation22
- Pain17
- Failure of Implant8
- No Information7
- Unspecified Infection7
- Ambulation or Postural Difficulties4
- Hematoma4
- Insufficient Information4
Biolox Option models
16 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Biolox® Option 00-8777-040-02Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 recall3 reports
- Biolox® Option 00-8777-040-01Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 recall0 reports
- Biolox® Option 00-8777-032-02Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented9 reports
- Biolox® Option 00-8777-036-02Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented8 reports
- Biolox® Option 00-8777-036-03Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented7 reports
- Biolox® Option 00-8777-032-03Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented6 reports
- Biolox® Option 00-8777-032-04Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented6 reports
- Biolox® Option 00-8777-028-02Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented5 reports
- Biolox® Option 00-8777-036-04Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented5 reports
- Biolox® Option 00-8777-028-03Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented4 reports
- Biolox® Option 00-8777-036-01Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented4 reports
- Biolox® Option 00-8777-040-04Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented4 reports
- Biolox® Option 00-8777-028-04Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented3 reports
- Biolox® Option 00-8777-040-03Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented2 reports
- Biolox® Option 00-8777-036-04Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- Biolox® Option 00-8777-028-01Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
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.
InjurySep 29, 2026Device Dislodged or Dislocated
Patient problems: Joint Contracture; Joint Dislocation; Scar Tissue
MAUDE report 50933410 ↗InjuryMay 21, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD UNDERGONE AN INITIAL LEFT TOTAL HIP ARTHROPLASTY APPROXIMATELY 12 YEARS EARLIER. AROUND MID-2021, THE PATIENT ACCIDENTALLY FELL AND SUSTAINED A SMALL FRACTURE TO THE ACETABULAR FLOOR BENEATH THE CUP. A FEW MONTHS LATER, RADIOGRAPHIC IMAGING DISPLAYED SINKING OF THE CUP WITH EVIDENT BONE DEFICIT AT THE ACETABULAR ROOF, AND SERUM COBALT AND CHROMIUM LEVELS WERE ELEVATED. SEVERAL MONTHS LATER, THE PATIENT UNDERWENT AN ACETABULAR REVISION AND REACTIVE GRAY SYNOVITIS OF A METALLOSIS TYPE AT THE STEM AND ACETABULUM, TRUNNIONOSIS, AND ABSENCE OF THE ANTERIOR WALL WITH EXTENSIVE ACETABULAR OSTEOLYSIS WERE FOUND. THE FRACTURED BONE FRAGMENT WAS SYNTHESIZED WITH TWO CORTICAL SCREWS AND ALL OTHER COMPONENTS WERE REVISED EXCEPT FOR THE STEM. POST-OPERATIVELY, THE PATIENT¿S HEMOGLOBIN DROPPED TO 7.6 G/DL AND REQUIRED ONE UNIT OF TRANSFUSED RED BLOOD CELLS. THE PATIENT WAS UNDERGOING A SLOW PROGRESSIVE RECOVERY AND, SEVERAL MONTHS LATER, AFTER A SHORT WALK WITH WEIGHT BEARING, HAD AN ONSET OF PAIN. RADIOGRAPHIC IMAGING DISPLAYED A PERIPROSTHETIC FLUID COLLECTION, RESORPTION OF THE GRAFT, AND CUP PROTRUSION, AND SUBSEQUENTLY THE PATIENT UNDERWENT AN ULTRASOUND
Patient problems: Anemia; Hematoma; Hemorrhage/Blood Loss/Bleeding; Inadequate Osseointegration; Joint effusion; Osteolysis; Pain; Unequal Limb Length
MAUDE report 25248523 ↗InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE PATIENT UNDERWENT A RIGHT HIP REVISION APPROXIMATELY 11 YEARS AND 7 MONTHS POST IMPLANTATION DUE TO TRUNNIONOSIS AND PSEUDOTUMOR, FOLLOWED BY A SECOND REVISION APPROXIMATELY 9 MONTHS LATER FOR GREATER TROCHANTER FRACTURE AND ABDUCTOR DEFICIENCY. DURING THE FIRST REVISION, THE CUP AND STEM WERE RETAINED. SUBSEQUENTLY, A SECOND REVISION WAS PERFORMED IN WHICH THE CUP AND STEM WERE AGAIN RETAINED, AND A CEMENTED CONSTRAINED LINER WAS PLACED. TRUNNIONOSIS WAS NOTED ON THE TRUNNION. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.
Patient problems: Bone Fracture(s); Metal Related Pathology; Muscle/Tendon Damage
MAUDE report 24079814 ↗InjuryAug 21, 2025Unstable; Unstable
InjuryJul 8, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.
Patient problems: Joint Dislocation
MAUDE report 22452494 ↗InjuryJul 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A HIP REVISION APPROXIMATELY 2 YEARS POST-IMPLANTATION DUE TO INSTABILITY FOR UNKNOWN REASONS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Joint Laxity
MAUDE report 22375295 ↗InjuryApr 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT THA. SUBSEQUENTLY, IT WAS REPORTED THE PATIENT HAD A RIGHT THA REVISION DUE TO METAL RELATED PATHOLOGY WITH LINER AND HEAD REVISED. SUBSEQUENTLY, AFTER APPROXIMATELY ONE YEAR AND FOUR MONTHS PATIENT REPORTS POST REVISION RIGHT HIP PAIN, LIMP, GIVING OUT OF HIP. TESTS REVEALED TROCHANTERIC BURSAL REACTIVE TISSUE, SURGEON DISCUSSED PLAN TO EXCISE THE AREA AND ASSESS FOR ANY FURTHER TISSUE DAMAGE AT THAT TIME. NO DOCUMENTATION PROCEDURE OR REVISION HAS OCCURRED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Ambulation or Postural Difficulties; Bursitis; Inflammation; Joint Impingement; Joint Laxity; Joint effusion; Metal Related Pathology; Pain
MAUDE report 21740079 ↗InjuryMar 26, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
InjuryNov 19, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Fall; Hematoma; Joint Dislocation; Tissue Breakdown
MAUDE report 20726695 ↗InjuryJun 4, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
DUE DILIGENCE HAS BEEN COMPLETED FOR THIS COMPLAINT; TO DATE ALL AVAILABLE ADDITIONAL INFORMATION HAS BEEN RECEIVED.
Patient problems: Failure of Implant; Joint Dislocation
MAUDE report 19459310 ↗InjuryJan 12, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED PATIENT UNDERWENT RIGHT HIP REVISION APPROXIMATELY 4 YEARS POST IMPLANTATION DUE TO DISLOCATED CONSTRAINED LINER. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Joint Dislocation
MAUDE report 18503125 ↗InjuryJan 2, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT PATIENT HAD DISLOCATION, DURING SURGICAL INTERVENTION PATIENT APPEARED TO PRESENT WITH TRUNION WEAR AND PSEUDOTUMOR POSSIBLY FROM METAL ION RELEASE. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.
Patient problems: Joint Dislocation
MAUDE report 18424470 ↗InjuryDec 5, 2023Migration; Migration
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Deformity/ Disfigurement; Failure of Implant; Pain; Unequal Limb Length
MAUDE report 18266928 ↗InjuryNov 30, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED PATIENT UNDERWENT AN INITIAL LEFT TOTAL HIP ARTHROPLASTY THAT LATER REQUIRED REVISION ON AN UNKNOWN DATE DUE TO UNKNOWN REASONS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Insufficient Information
MAUDE report 18241611 ↗InjuryNov 29, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT UNDERWENT HIP REVISION APPROXIMATELY 8 MONTHS POST IMPLANTATION DUE TO INTRA PROSTHETIC DISLOCATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Joint Dislocation
MAUDE report 18231122 ↗
Other Zimmer GmbH products
- Affixus Natural Nail55 models · 612 reports
- Biolox delta16 models · 343 reports
- NCB78 models · 200 reports
- Zimmer Natural Nail System57 models · 187 reports
- Avenir24 models · 57 reports · 1 recall
- Anatomical Shoulder33 models · 102 reports
- Sidus Stem-Free Shoulder9 models · 30 reports · 1 recall
- Wagner SL Revision33 models · 66 reports
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 13, 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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