Biolox® delta 00-8775-040-03Recalls & reported problems
Zimmer GmbH · BIOLOX® DELTA, FEMORAL HEAD, L, CERAMIC, Ø 40/+3.5, 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
- 11
- Deaths reported
- 0
- Injuries reported
- 11
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00889024430419), received between Feb 19, 2019 and Jul 4, 2024 — classified as 11 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (6 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 Dislocated6
- Insufficient Device Problem Information3
- Adverse Event Without Identified Device or Use Problem1
- Fracture1
- Noise, Audible1
Patient problems
- Joint Dislocation5
- No Information2
- Unspecified Infection2
- Failure of Implant1
- Fluid Discharge1
- Numbness1
- Pain1
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
InjuryJul 4, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY DUE TO DISLOCATION APPROXIMATELY 2-MONTHS POST IMPLANTATION. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.
Patient problems: Failure of Implant; Joint Dislocation
MAUDE report 19674787 ↗InjuryJul 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT APPROXIMATELY THREE YEARS POST-IMPLANTATION, THE PATIENT REPORTS ONGOING RIGHT HIP PAIN AND NUMBNESS FROM HIP TO FOOT. ANOTHER REVISION IS BEING PLANNED BUT IT IS UNKNOWN IF A REVISION HAS BEEN SCHEDULED TO DATE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Numbness; Pain
MAUDE report 19665118 ↗InjuryFeb 27, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Joint Dislocation
MAUDE report 16442260 ↗InjuryFeb 27, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Joint Dislocation
MAUDE report 16442255 ↗InjuryFeb 27, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Joint Dislocation
MAUDE report 16442011 ↗InjuryFeb 27, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Joint Dislocation
MAUDE report 16441722 ↗InjuryJan 13, 2020Fracture; Noise, Audible; Fracture; Noise, Audible
PATIENT WAS IMPLANTED ON AN UNKNOWN SIDE AND UNDERWENT REVISION SURGERY DUE TO IMPLANT FRACTURE, FLUID COLLECTION AND SQUEAKY NOISE.
Patient problems: Fluid Discharge
MAUDE report 9580424 ↗InjuryAug 16, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated
InjuryApr 24, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT UNDERWENT DEBRIDEMENT AND VSD SUCTION DUE TO INFECTION APPROXIMATELY 5 MONTHS AFTER IMPLANTATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.
Patient problems: Unspecified Infection
MAUDE report 8543912 ↗InjuryApr 23, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT UNDERWENT DEBRIDEMENT AND VSD SUCTION DUE TO INFECTION APPROXIMATELY 5 MONTHS AFTER IMPLANTATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.
Patient problems: Unspecified Infection
MAUDE report 8539323 ↗InjuryFeb 19, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY DUE TO UNKNOWN REASON. NOTE: AT THE MOMENT IT IS UNKNOWN WHETHER OR WHAT TYPE OF DEVICE HAVE BEEN EXPLANTED DURING THIS REVISION SURGERY. INFORMATION HAS BEEN REQUESTED.
Patient problems: No Information
MAUDE report 8349659 ↗
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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