Biolox® Option 00-8777-032-02Recalls & reported problems
Zimmer GmbH · BIOLOX® OPTION, HEAD, M, Ø 32/0, 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
- 9
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00889024430488), received between Nov 7, 2018 and Jan 12, 2024 — classified as 9 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (5 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 Dislocated5
- Adverse Event Without Identified Device or Use Problem1
- Fracture1
- Insufficient Device Problem Information1
- Loosening of Implant Not Related to Bone-Ingrowth1
- Naturally Worn1
- Patient Device Interaction Problem1
Patient problems
- Pain3
- Failure of Implant2
- No Information2
- Bone Fracture(s)1
- Fall1
- Foreign Body Reaction1
- Joint Dislocation1
- Joint Laxity1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
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 ↗InjuryApr 14, 2022Patient Device Interaction Problem; Patient Device Interaction Problem
IT WAS REPORTED THAT THE PATIENT HAD PAIN AND ELEVATED COBALT LEVELS. PATIENT OUTCOME - REVISION DUE TO PAIN AND ELEVATED METAL ION LEVELS. THIS ITEM WILL NOT BE SENT BACK. IT WAS RETAINED BY THE HOSPITAL. BODY SIDE: LEFT.
Patient problems: Metal Related Pathology; Pain
MAUDE report 14110123 ↗InjuryMar 1, 2021Fracture; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Fracture; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth
NO CHANGE TO PREVIOUSLY REPORTED EVENT.
Patient problems: Bone Fracture(s); Failure of Implant; Fall; Joint Laxity
MAUDE report 11392240 ↗InjuryFeb 18, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
InjuryAug 27, 2019Naturally Worn; Naturally Worn
IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY DUE TO POLY WEAR.
Patient problems: Failure of Implant
MAUDE report 8935357 ↗InjuryJun 27, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated
PATIENT WAS IMPLANTED ON THE RIGHT SIDE AND UNDERWENT CLOSED REDUCTION DUE TO PAIN AND MULTIPLE DISLOCATIONS. (FIRST DISLOCATION)
Patient problems: Pain
MAUDE report 8738526 ↗InjuryJun 27, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated
PATIENT WAS IMPLANTED ON THE RIGHT SIDE AND UNDERWENT CLOSED REDUCTION DUE TO PAIN AND MULTIPLE DISLOCATIONS.(SECOND DISLOCATION)
Patient problems: Pain
MAUDE report 8738524 ↗InjuryMay 7, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated
PLEASE REFER TO REPORT 0009613350-2019-00286.
Patient problems: Foreign Body Reaction
MAUDE report 8586858 ↗InjuryNov 7, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
A PATIENT IS PURSUING A PRODUCT LIABILITY CLAIM BECAUSE UNDERWENT REVISION SURGERY. UNKNOWN AT THE MOMENT THE REASON.
Patient problems: No Information
MAUDE report 8046013 ↗
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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