Biolox® delta 00-8775-032-04Recalls & reported problems
Zimmer GmbH · BIOLOX® DELTA, CERAMIC FEMORAL HEAD, XL, Ø 32/+7, TAPER 12/14 · Class 2 · Implant
All models of Biolox delta (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 00889024430341), received between Nov 30, 2018 and Jun 9, 2022 — classified as 7 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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 Dislocated4
- Unstable2
- Appropriate Device Problem Term/Code Not Available1
- Inadequacy of Device Shape and/or Size1
Patient problems
- Joint Dislocation2
- No Code Available2
- Failure of Implant1
- No Information1
- Pain1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryJun 9, 2022Unstable; Device Dislodged or Dislocated; Unstable; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE OF THE RIGHT HIP APPROXIMATELY 2 MONTHS POST IMPLANTATION DUE TO DISLOCATION.
Patient problems: Joint Dislocation
MAUDE report 14641303 ↗InjuryOct 27, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
InjuryJul 28, 2020Unstable; Unstable
PATIENT WAS IMPLANTED ON RIGHT SIDE AND UNDERWENT REVISION SURGERY DUE TO JOINT INSTABILITY. STEM, INSERT AND HEAD WERE REVISED.
Patient problems: No Code Available
MAUDE report 10332525 ↗InjuryApr 9, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
InjuryMar 13, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated
A PATIENT IS PURSUING A PRODUCT LIABILITY CLAIM DUE TO REVISION SURGERY FOLLOWING REPETITIVE LUXATIONS.
Patient problems: Failure of Implant
MAUDE report 8417293 ↗InjuryMar 13, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated
A PATIENT IS PURSUING A PRODUCT LIABILITY CLAIM. IT WAS REPORTED THAT THE PATIENT HAD A CLOSED REDUCTION PROCEDURE APPROXIMATELY FIVE DAYS POST IMPLANTATION DUE TO DISLOCATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.
Patient problems: No Information
MAUDE report 8417226 ↗InjuryNov 30, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
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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