Biolox® delta 00-8775-032-03Recalls & reported problems
Zimmer GmbH · BIOLOX® DELTA, CERAMIC FEMORAL HEAD, L, Ø 32/+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
- 17
- Deaths reported
- 0
- Injuries reported
- 15
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00889024430334), received between Dec 17, 2018 and May 19, 2025 — classified as 15 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (7 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 Dislocated7
- Insufficient Device Problem Information3
- Adverse Event Without Identified Device or Use Problem2
- Activation, Positioning or Separation Problem1
- Human-Device Interface Problem1
- Migration or Expulsion of Device1
- Off-Label Use1
- Patient Device Interaction Problem1
Patient problems
- Pain7
- Failure of Implant5
- Joint Dislocation4
- No Code Available2
- Ambulation or Postural Difficulties1
- Fall1
- Loss of Range of Motion1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.
InjuryMay 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY LEGAL THAT A PATIENT HAD AN INITIAL LEFT TOTAL HIP ARTHROPLASTY PERFORMED. SUBSEQUENTLY, APPROXIMATELY 6 MONTHS POST-IMPLANTATION THE PATIENT HAS REPORTED ONGOING PAIN AND DECREASED QUALITY OF LIFE SINCE IMPLANTATION. PATIENT RELAYS FEAR OF NOT BEING ABLE TO WALK UNAIDED IN THE FUTURE. NO FURTHER INFORMATION HAS BEEN PROVIDED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Ambulation or Postural Difficulties; Pain
MAUDE report 22045318 ↗InjuryFeb 5, 2025Off-Label Use; Off-Label Use
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21313619 ↗InjurySep 17, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.
Patient problems: Failure of Implant; Joint Dislocation
MAUDE report 20239026 ↗InjurySep 16, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
DUE DILIGENCE HAS BEEN COMPLETED FOR THIS COMPLAINT; TO DATE ALL AVAILABLE ADDITIONAL INFORMATION HAS BEEN RECEIVED.
Patient problems: Joint Dislocation; Subluxation
MAUDE report 20224705 ↗MalfunctionNov 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT HAD PAIN 6 WEEKS AFTER IMPLANTATION, PREDOMINANTLY LOCALIZED AT SI-JOINT. IT WAS RECOMMENDED TO USE CRUTCHES FOR A FEW WEEKS AND THE PAIN HAS GONE AWAY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Pain
MAUDE report 18231979 ↗InjuryFeb 1, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A FALL APPROXIMATELY NINE YEARS POST IMPLANTATION ON AN UNKNOWN DATE AND NOW IS EXPERIENCING HIP PAIN. NO INTERVENTION HAS BEEN REPORTED TO DATE. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.
Patient problems: Fall; Pain
MAUDE report 16276249 ↗InjuryJun 23, 2022Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem
IT WAS REPORTED THE PATIENT UNDERWENT A RIGHT HIP PROCEDURE. SUBSEQUENTLY, THE PATIENT STATES TO HAVE HAD PAIN IN THE GROIN AND BOTH LEGS SINCE THE PROCEDURE. THE DOCTOR TOLD THE PATIENT THAT THE IMPLANTS WERE INSTALLED CROOKED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Pain
MAUDE report 14784941 ↗InjuryApr 28, 2022Human-Device Interface Problem; Human-Device Interface Problem
IT WAS REPORTED THAT: TOTAL HIP REPLACEMENT ON RIGHT HIP DONE IN (B)(6) HOSPITAL. REASON FOR REVISION IS DISLOCATION.PATIENT INVOLVEMENT-REVISION.
Patient problems: Joint Dislocation
MAUDE report 14235452 ↗InjuryJun 18, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
PATIENT WAS IMPLANTED ON THE RIGHT SIDE AND UNDERWENT REVISION DUE TO PAIN, DISLOCATION, SUBLUXATION AND NOISE.
Patient problems: Failure of Implant; Pain
MAUDE report 10166843 ↗InjuryJun 18, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
PATIENT WAS IMPLANTED ON THE RIGHT SIDE AND TREATED WITH CLOSED REDUCTION FOR DISLOCATION.
Patient problems: Pain
MAUDE report 10166838 ↗InjuryMar 18, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORT ED THAT PATIENT UNDERWENT REVISION SURGERY DUE TO INSTABILITY.
Patient problems: No Code Available
MAUDE report 9847867 ↗InjuryNov 18, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated
InjuryOct 15, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated
NO CHANGE TO PREVIOUSLY REPORTED EVENT.
Patient problems: Failure of Implant; Joint Dislocation
MAUDE report 9191213 ↗InjuryAug 22, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
CLINICAL STUDY REPORTED THAT 5 YEAR AFTER IMPLANTATION PATIENT REPORTED MODERATE PAIN, DISCOMFORT, MARKEDLY SLOWER AND ALTERED GAIT MOVEMENT. THE PRODUCT IS STILL IMPLANTED.
Patient problems: Loss of Range of Motion; Pain
MAUDE report 8919647 ↗InjuryApr 12, 2019Migration or Expulsion of Device; Migration or Expulsion of Device
PLEASE REFER TO REPORT 0009613350-2019-00213.
Patient problems: Failure of Implant
MAUDE report 8507623 ↗InjuryMar 27, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated
MalfunctionDec 17, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
NOTE: UPON INVESTIGATION AND RECEIVING FURTHER INFORMATION FROM SOURCE, BONE CONDENSATION IS AN EXPECTED FINDING INDICATING OSTEOINTEGRATION. THERE IS NO INJURY OR INTERVENTION NOTED AS A RESULT OF THIS FINDING AS IT IS CONSIDERED EXPECTED. THEREFORE, THIS COMPLAINT SHALL BE SET TO NOT A COMPLAINT. PLEASE DELETE THIS CASE FROM YOUR SYSTEM.
Patient problems: No Code Available
MAUDE report 8168255 ↗
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