Biolox® Option 00-8777-036-03Recalls & reported problems
Zimmer GmbH · BIOLOX® OPTION, HEAD, L, Ø 36/+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
- 7
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00889024430532), received between Mar 19, 2019 and Feb 17, 2023 — classified as 7 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.
Most reported problems
Device problems
- Device Dislodged or Dislocated5
- Insufficient Device Problem Information2
- Unintended Movement1
Patient problems
- Joint Dislocation4
- Pain3
- Swelling/ Edema2
- Ambulation or Postural Difficulties1
- Implant Pain1
- Thromboembolism1
- Unspecified Infection1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryFeb 17, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Ambulation or Postural Difficulties; Joint Dislocation; Pain; Swelling/ Edema
MAUDE report 16396257 ↗InjuryAug 23, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
PATIENT WAS IMPLANTED ON THE RIGHT SIDE AND 2 WEEKS POST-IMPLANTATION NOTICED THAT HIS HIP RANDOMLY POPPED OUT WHILE SLEEPING. THE PATIENT STATES HE WAS ABLE TO SPONTANEOUSLY REDUCE IT BY HIMSELF BY STANDING ON THE HIP, BUT SINCE THEN HE HAS EXPERIENCED WORSENING SWELLING AND PAIN.
Patient problems: Implant Pain; Joint Dislocation; Pain; Swelling/ Edema
MAUDE report 12353494 ↗InjuryApr 9, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
A PATIENT IS PURSUING A PRODUCT LIABILITY CLAIM FOLLOWING A SPONTANEOUS HIP DISLOCATION OF THE HEAD AND LINER OF THE RIGHT HIP ONE YEAR POST-OP. PATIENT WAS REDUCED UNDER SEDATION.
Patient problems: Joint Dislocation
MAUDE report 9942422 ↗InjuryFeb 10, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
PATIENT WAS IMPLANTED ON THE RIGHT SIDE AND UNDERWENT REVISION SURGERY DUE TO RECURRENT DISLOCATION AND PAIN.
Patient problems: Pain
MAUDE report 9688393 ↗InjuryJul 5, 2019Device Dislodged or Dislocated; Unintended Movement; Device Dislodged or Dislocated; Unintended Movement
PLEASE REFER TO REPORT 0009613350-2019-00423.
Patient problems: Joint Dislocation
MAUDE report 8764047 ↗InjuryJun 19, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
InjuryMar 19, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
NO CHANGE TO PREVIOUSLY REPORTED EVENT.
Patient problems: Unspecified Infection
MAUDE report 8432472 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page