Biolox® Option 00-8777-032-03Recalls & reported problems
Zimmer GmbH · BIOLOX® OPTION, HEAD, L, Ø 32/+3.5, TAPER 12/14 · Class 2 · Implant
All models of Biolox Option (16)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00889024430495), received between Aug 26, 2019 and Jan 15, 2026 — classified as 6 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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
- Device Dislodged or Dislocated3
- Adverse Event Without Identified Device or Use Problem1
- Insufficient Device Problem Information1
- Unstable1
Patient problems
- Pain2
- Bone Fracture(s)1
- Joint Dislocation1
- Joint Laxity1
- Metal Related Pathology1
- Muscle/Tendon Damage1
- No Information1
- Swelling1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
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
InjuryOct 21, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED PATIENT EXPERIENCED A HIP DISLOCATION APPROXIMATELY TWO MONTHS POST-IMPLANTATION. PATIENT EXPERIENCED A SECOND HIP DISLOCATION APPROXIMATELY THREE MONTHS POST-IMPLANTATION. DUE DILIGENCE IS IN PROGRESS FOR THIS EVENT; TO DATE NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Joint Dislocation
MAUDE report 15651756 ↗InjuryNov 5, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
InjuryAug 28, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated
InjuryAug 26, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH BIOLOX HEAD. PATIENT SUBSEQUENTLY UNDERWENT A REVISION SURGERY DUE TO DISLOCATION.
Patient problems: No Information
MAUDE report 8930329 ↗
Other Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented devices
- BIOLOX DELTA 1365-32-310Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented551 reports
- PINNACLE ALTRX 1221-36-052Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented481 reports
- BIOLOX DELTA 1365-32-320Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 death314 reports
- BIOLOX DELTA 1365-36-720Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 death189 reports
- DJO SURGICAL 400-03-362Encore Medical, L.P. · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented187 reports
- Anthology 71365705Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented176 reports
- BIOLOX DELTA 1365-40-710Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented170 reports
- PINNACLE GRIPTION 1217-32-054Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented169 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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