Biolox® delta 00-8775-028-02Recalls & reported problems
Zimmer GmbH · BIOLOX® DELTA, CERAMIC FEMORAL HEAD, M, Ø 28/0, 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 (femoral head, 28 mm) is used in hip replacement surgery. The 36 adverse event reports mostly describe the hip joint coming apart or dislocating after surgery, sometimes soon after implantation and sometimes years later, with several patients needing revision surgery to replace the stem, neck or bearing parts. There were 33 injuries and no deaths. Three malfunctions were also reported, including a head that did not seat properly in its bearing. No recalls name 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
- 37
- Deaths reported
- 0
- Injuries reported
- 34
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 00889024430297), received between Mar 5, 2019 and Sep 29, 2026 — classified as 34 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (19 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 Dislocated19
- Adverse Event Without Identified Device or Use Problem9
- Detachment of Device or Device Component3
- Fracture2
- Insufficient Device Problem Information2
- Activation, Positioning or Separation Problem1
- Biocompatibility1
- Mechanical Problem1
Patient problems
- Joint Dislocation19
- Failure of Implant8
- Pain4
- Unspecified Infection4
- Fall3
- Ambulation or Postural Difficulties2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Bone Fracture(s)1
Recent adverse event reports
The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Naturally Worn
Patient problems: Insufficient Information
MAUDE report 50932266 ↗InjuryMay 15, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIP REVISION APPROXIMATELY 19 MONTHS POST-IMPLANTATION DUE TO A DISASSOCIATED DUAL MOBILITY BEARING AND HEAD. NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Joint Dislocation
MAUDE report 25179916 ↗InjuryFeb 19, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT UNDERWENT PRIMARY SURGERY, AND SUBSEQUENTLY FELL BACKWARD, RESULTING IN AN ANTERIOR DISLOCATION AND REQUIRING REVISION SURGERY APPROXIMATELY 2 YEARS, 8 MONTHS POST PRIMARY SURGERY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Joint Dislocation
MAUDE report 24386196 ↗InjuryJan 2, 2026Adverse Event Without Identified Device or Use Problem
THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.
Patient problems: Unspecified Infection
MAUDE report 23941631 ↗InjuryOct 28, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Joint Dislocation; Metal Related Pathology
MAUDE report 23405138 ↗InjuryJul 22, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THE PATIENT UNDERWENT A HIP REVISION APPROXIMATELY 1 WEEK POST IMPLANTATION DUE TO DISLOCATION. THERE WAS EARLY POSTOPERATIVE DISLOCATION; STEM AND NECK WERE REPLACED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Joint Dislocation
MAUDE report 22565394 ↗InjuryJun 9, 2025Separation Failure; Detachment of Device or Device Component; Separation Failure; Detachment of Device or Device Component
IT WAS REPORTED THAT PATIENT UNDERWENT A REVISION APPROXIMATELY 3 YEARS POST IMPLANTATION DUE TO IMPLANT DISASSEMBLY (BETWEEN BEARING AND HEAD). ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Failure of Implant
MAUDE report 22168862 ↗InjuryApr 25, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED PATIENT UNDERWENT HIP REVISION APPROXIMATELY 1 YEAR AND 4 MONTHS POST IMPLANTATION DUE TO DISLOCATION. MODULAR NECK, HEAD, AND DM BEARINGS WERE REPLACED IN THIS SURGERY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Joint Dislocation
MAUDE report 21909738 ↗MalfunctionAug 8, 2024Positioning Problem; Positioning Problem
IT WAS REPORTED IN HIP REPLACEMENT THAT THE HEAD DO NOT ASSEMBLY AS INTENDED WITHIN THE BEARING DISPLAYED SIGNIFICANT PLAY. THERE WAS NO SURGICAL DELAY OR COMPLICATIONS. FOREIGN BODY WAS NOT RETAINED. ANOTHER HEAD WAS USED TO COMPLETE THE SURGERY. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.
Patient problems: Failure of Implant
MAUDE report 19944024 ↗InjuryAug 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT APPROXIMATELY TWO YEARS POST-IMPLANTATION, THE PATIENT UNDERWENT A RIGHT HIP REVISION DUE TO INSTABILITY. THE BEARING AND HEAD WERE REVISED. DUE DILIGENCE HAS BEEN COMPLETED FOR THIS COMPLAINT; TO DATE ALL AVAILABLE ADDITIONAL INFORMATION HAS BEEN RECEIVED.
Patient problems: Joint Laxity
MAUDE report 19938325 ↗InjuryJul 8, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT APPROXIMATELY ONE DAY POST-IMPLANTATION, THE PATIENT UNDERWENT A HIP REVISION DUE TO A FALL AND HIP DISLOCATION. DURING SURGERY, THE SURGEON FOUND AN INTRA-PROSTHETIC DISLOCATION OF THE HEAD OUT OF THE BEARING. THE HEAD AND BEARING WERE REVISED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Failure of Implant; Fall; Joint Dislocation; Pain
MAUDE report 19691718 ↗InjuryJul 3, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIP PROCEDURE AND SUBSEQUENTLY WAS REVISED APPROXIMATELY 5 YEARS POST IMPLANTATION DUE TO DISLOCATION. THE CAUSE OF THE DISLOCATION IS UNKNOWN. THE STEM, HEAD, AND BEARING WERE REPLACED. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.
Patient problems: Joint Dislocation
MAUDE report 19665405 ↗InjuryApr 11, 2024Fracture; Fracture
IT WAS REPORTED IN A PRIMARY HIP SURGERY THE CERAMIC HEAD WAS CHIPPED FRACTURED/CHIPPED DURING IMPACTION. THERE WAS NO IMPACT TO PATIENT AND THE SURGERY WAS COMPLETED WITH ANOTHER HEAD. DILIGENCE IS COMPLETED AND ADDITIONAL INFORMATION IS UNAVAILABLE AT THIS TIME.
Patient problems: Failure of Implant
MAUDE report 19088892 ↗InjuryAug 29, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT A PATIENT WITH A HISTORY OF RHEUMATOID ARTHRITIS AND SCOLIOSIS UNDERWENT INITIAL RIGHT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY EXPERIENCED RECURRENT DISLOCATIONS AND UNDERWENT FIRST REVISION SURGERY. DURING WHICH, THE INITIAL SHELL WAS RETAINED, AND A NEW STEM, HEAD, AND DUAL MOBILITY BEARING WERE PLACED ALONG WITH A COMPETITOR METAL LINER. A FEW MONTHS LATER, THE PATIENT BENT OVER AND AGAIN DISLOCATED HER HIP WHICH WAS REDUCED IN THE EMERGENCY DEPARTMENT. X-RAYS SHOWED DISSOCIATION OF THE DUAL MOBILITY HEAD FROM THE BEARING. PATIENT UNDERWENT SECOND REVISION SURGERY DURING WHICH, THE COMPETITOR METAL LINER AND DUAL MOBILITY COMPONENTS WERE REPLACED WITH A NEW CERAMIC HEAD AND COMPETITOR CONSTRAINED LINER . THE INITIAL SHELL AND REVISION STEM REMAINED INTACT. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.
Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Joint Dislocation
MAUDE report 17641151 ↗InjuryAug 23, 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 17601590 ↗InjuryAug 18, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED A PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT DISLOCATED WHICH WAS NOT REDUCIBLE. THE PATIENT WAS SUBSEQUENTLY REVISED AS IT WAS FOUND THERE WAS DISASSOCIATION OF THE IMPLANTS. ATTEMPTS HAVE BEEN MADE AND ALL ADDITIONAL INFORMATION RECEIVED HAS BEEN INCLUDED IN THIS REPORT.
Patient problems: Joint Dislocation
MAUDE report 17571839 ↗InjuryJul 17, 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 17332383 ↗InjuryMay 12, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant; High metal ion levels; Pain
MAUDE report 16917627 ↗MalfunctionSep 5, 2022Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem
IT WAS REPORTED THAT THE CERAMIC HEAD DID NOT ARTICULATE CORRECTLY WITHIN THE E1 BIPOLAR LINER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT HEAD AND LINER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15354428 ↗InjuryAug 30, 2022Unintended Movement; Unintended Movement
IT WAS REPORTED PATIENT UNDERWENT A LEFT HIP REVISION APPROXIMATELY 2 MONTHS¿ POST IMPLANTATION DUE TO A DISLOCATION AFTER A FALL. BEFORE THE REVISION, THE ER FAILED TO COMPLETE A CLOSED REDUCTION. WHILE TRYING TO REDUCE THE HIP, THE CUP THEN DISASSOCIATED FROM THE ACETABULUM, DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.
Patient problems: Joint Dislocation
MAUDE report 15318170 ↗InjuryAug 25, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL HIP ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO DISLOCATION AFTER A FALL. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE, NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.
Patient problems: Fall; Joint Dislocation
MAUDE report 15291247 ↗InjuryJun 28, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION OF THE HIP TWO DAYS AFTER IMPLANTATION. NO FURTHER PATIENT OUTCOME PROVIDED.
Patient problems: Joint Dislocation
MAUDE report 14840847 ↗InjuryApr 28, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT: ACTIVE ARTICULATION BEARING WAS DISLOCATED DUE TO DISASSOCIATION. THE SURGEON DID NOT COMMENT ON THIS PATIENT'S FACTORS FOR THE DISLOCATION. THE MODULAR HEAD AND NECK WERE ALSO REPLACED IN THIS REVISION SURGERY. PATIENT OUTCOME - REVISION DUE TO DISLOCATION.
Patient problems: Joint Dislocation
MAUDE report 14239274 ↗InjurySep 3, 2021Adverse Event Without Identified Device or Use Problem
InjuryAug 25, 2021Fracture; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO EVENT UPDATE. INVESTIGATION RESULTS ARE NOW AVAILABLE.
Patient problems: Bone Fracture(s)
MAUDE report 12364198 ↗
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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