Biolox® delta 00-8775-036-01Recalls & reported problems
Zimmer GmbH · BIOLOX® DELTA, CERAMIC FEMORAL HEAD, S, Ø 36/-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
Quick summary
This Zimmer BIOLOX delta ceramic hip implant (small femoral head,36mm) is used in total hip replacement. The 35 reports mostly describe pain, the hip joint coming dislocated or the implant loosening, and patients needing revision surgery; 31 reports involved injuries and no deaths were reported. There are no recalls naming this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 35
- Deaths reported
- 0
- Injuries reported
- 31
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 00889024430358), received between Jan 7, 2020 and Aug 10, 2026 — classified as 31 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (9 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
- Adverse Event Without Identified Device or Use Problem16
- Device Dislodged or Dislocated9
- Insufficient Device Problem Information2
- Mechanical Jam2
- Patient-Device Incompatibility2
- Scratched Material2
- Appropriate Device Problem Term/Code Not Available1
- Contamination /Decontamination Problem1
Patient problems
- Pain9
- Joint Dislocation7
- Unspecified Infection6
- Failure of Implant4
- No Clinical Signs, Symptoms or Conditions4
- Ambulation or Postural Difficulties3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Insufficient Information2
Recent adverse event reports
The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.
InjuryAug 10, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient underwent a hip revision. During the procedure the Head and Liner were revised.It was confirmed that no further information could be provided.
Patient problems: Insufficient Information
MAUDE report 50190502 ↗InjuryAug 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.
Patient problems: Bursitis
MAUDE report 22815831 ↗InjuryMay 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Loss of Range of Motion; Pain; Tendinopathy
MAUDE report 22036027 ↗InjuryMay 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.
Patient problems: Tendinopathy
MAUDE report 22029348 ↗InjuryMar 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Thrombosis/Thrombus
MAUDE report 21701029 ↗InjuryJan 30, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.
Patient problems: Joint Dislocation
MAUDE report 21278406 ↗InjuryOct 9, 2024Noise, Audible; Noise, Audible
NO ADDITIONAL EVENT INFORMATION AT THIS TIME.
Patient problems: Failure of Implant
MAUDE report 20409167 ↗InjuryJul 2, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT A PATIENT UNDERWENT A HIP ARTHROPLASTY AND APPROXIMATELY ONE-MONTH LATER WAS REVISED DUE TO DISLOCATION. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.
Patient problems: Joint Dislocation
MAUDE report 19656552 ↗InjuryMar 4, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT PATIENT UNDERWENT REVISION APPROXIMATELY 2 YEARS POST IMPLANTATION DUE TO RECURRENT DISLOCATIONS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Joint Dislocation
MAUDE report 18828949 ↗InjuryDec 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 14, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT REPORTED SUBLUXATION OF HIP. HIP WAS REVISED AND FEMORAL HEAD WAS REPLACED WITH AN INCREASED OFFSET. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.
Patient problems: Subluxation
MAUDE report 18131426 ↗InjuryOct 4, 2023Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant; Inflammation; Pain; Solid Tumor
MAUDE report 17866440 ↗InjuryAug 18, 2023Difficult to Insert; Difficult to Insert
IT WAS REPORTED THAT THE PATIENT UNDERWENT LEFT HIP TOTAL HIP ARTHROPLASTY TWENTY-EIGHT DAYS AGO. THE PATIENT HAD ALREADY CONFIRMED THE USE OF FORTY-SIX MM ACETABULAR CUP AND THE CORRESPONDING LINER, HOWEVER DURING IMPLANTATION THE SURGEON FOUND THAT THE LINER COULD NOT BE MATCHED TO THE OUTER CUP SIZE AND THE LINER COULD NOT BE STRUCK INTO PLACE AFTER A FEW TRIES, AND BY THIS TIME, THE PATIENT HAD ALREADY SUFFERED FROM A BONE FRACTURE. AFTER REMOVING THE OUTER CUP, IT WAS NECESSARY TO USE A PERCUSSION DISK TO STRIKE THE OUTER CUP OUTSIDE THE PATIENT'S BODY, AND THE SHALLOW THREADS ON THE HEAD OF THE OUTER CUP CONNECTING ROD COULD NOT BE MATCHED WITH THE PERCUSSION DISK. IMMEDIATELY AFTER IMPLANTING THE CUP AGAIN WITH A FORTY-EIGHT MM OUTER CUP, THE BOTTOM OF THE ACETABULUM WAS PIERCED DURING LINER STRIKING, AND THE CUP WAS UNSTABLE, SO THE ACETABULAR CUP SIZE WAS ENLARGED WITH A FIFTY-SIX MM OUTER CUP BEFORE IT WAS PLACED SECURELY, AND A 190/20 STEM WAS USED TO EXPAND THE FEMORAL SIDE OF THE ACETABULUM, WHICH WAS ALSO SMALL. SURGEON USED A CEMENTED FILLER AND PLACED THE 190/20 STEM, HOWEVER DUE TO THE HEIGHT PROBLEM, THE BOTTOM OF THE ACETABULUM AND THE ACETABULAR RIM WERE DAMAGED
Patient problems: Bone Fracture(s); Hemorrhage/Blood Loss/Bleeding
MAUDE report 17570384 ↗InjuryAug 7, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Foreign Body In Patient; Joint Dislocation
MAUDE report 17469329 ↗InjuryJul 31, 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 17423471 ↗InjuryApr 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY FOR ASEPTIC LOOSENING OF THE FEMORAL COMPONENT CAUSED BY TRAUMA DUE TO A FALL; APPROXIMATELY TWO (2) YEARS THREE (3) MONTHS FROM INITIAL TOTAL HIP ARTHROPLASTY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Joint Impingement; Osteopenia/ Osteoporosis; Pain
MAUDE report 16680702 ↗MalfunctionAug 22, 2022Defective Component; Defective Component
IT WAS REPORTED THAT DURING THE SURGERY, UPON OPENING THE STERILE IMPLANT, THE SURGEON FOUND A HAIR ON THE FEMORAL HEAD. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15264457 ↗InjuryMay 6, 2022Degraded; Adverse Event Without Identified Device or Use Problem; Degraded; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL LEFT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO UNKNOWN REASONS. THE CUP, LINER AND HEAD WERE REMOVED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 14301041 ↗InjuryApr 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD UNDERGONE AN INITIAL LEFT HIP ARTHROPLASTY DUE TO ANKYLOSING SPONDYLITIS AND WAS DISCHARGED WITH A GOOD RECOVERY. AFTER THE OPERATION, THE PATIENT DEVELOPED REDNESS AND PAIN IN THE LEFT HIP AND UNDERWENT DEBRIDEMENT TREATMENT. PATIENT WAS DISCHARGED WITH A GOOD RECOVERY AFTERWARDS. THE PATIENT'S INFECTION WAS REPORTED TO BE SUPERFICIAL; THE JOINT CAVITY WAS NOT OPENED AND THE JOINT PROSTHESIS WAS NOT EXPOSED. HOSPITAL REPORTED THE EVENT AS PATIENT'S OWN CAUSE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED. INVESTIGATION HAS BEEN COMPLETED.
Patient problems: Pain; Unspecified Infection
MAUDE report 14042906 ↗InjuryFeb 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A LEFT HIP CLOSED REDUCTION WAS PERFORMED DUE TO DISLOCATION POTENTIALLY RELATED TO THE DEVICE AND/OR PROCEDURE.
Patient problems: Ambulation or Postural Difficulties; Joint Dislocation; Pain; Swelling/ Edema; Unequal Limb Length
MAUDE report 13558178 ↗MalfunctionDec 8, 2021Material Integrity Problem; Scratched Material; Material Integrity Problem; Scratched Material
IT WAS REPORTED THAT A DURING SURGERY THE SURGEON NOTICED A SCRATCH ON THE FEMORAL HEAD SURFACE. NO IMPACT ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12959278 ↗InjuryDec 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO INFECTION. SIDE: LEFT.
Patient problems: Unspecified Infection
MAUDE report 12934153 ↗MalfunctionApr 29, 2021Difficult to Remove; Material Separation; Mechanical Jam; Difficult to Remove; Material Separation; Mechanical Jam
INVESTIGATION RESULTS ARE AVAILABLE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions
MAUDE report 11744322 ↗InjuryApr 14, 2021Patient-Device Incompatibility; Insufficient Device Problem Information; Patient-Device Incompatibility; Insufficient Device Problem Information
InjuryFeb 4, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS IMPLANTED ON THE RIGHT SIDE AND UNDERWENT REVISION SURGERY DUE TO INFECTION AND PAIN.
Patient problems: Fluid Discharge; Pain; Unspecified Infection; Wound Dehiscence
MAUDE report 11278408 ↗
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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