BIOLOX DELTA 1365-32-730Recalls & reported problems
Depuy Orthopaedics, Inc. · BIOLOX DELTA TS CERAMIC FEMORAL HEAD 12/14 TAPER REVISION Diameter 32mm +9 · Class 3 · Implant
All models of BIOLOX DELTA (40)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy BIOLOX Delta ceramic femoral head is a hip replacement component. Its 92 reports, with 91 injuries and no deaths, mostly describe the hip dislocating, and some describe infection, pain, or loose joints. No recalls name this device. Reports for the last 12 months (7) are fewer than in the previous 12 months (11).
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
- 93
- Deaths reported
- 0
- Injuries reported
- 92
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 93 adverse event reports that list this exact device (DI 10603295033486), received between Jul 21, 2017 and Jul 27, 2026 — classified as 92 injuries, 1 malfunction.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (57 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 Dislocated57
- Adverse Event Without Identified Device or Use Problem31
- Noise, Audible5
- Insufficient Device Problem Information3
- Naturally Worn3
- Appropriate Device Problem Term/Code Not Available2
- Biocompatibility1
- Device Contaminated During Manufacture or Shipping1
Patient problems
- Joint Dislocation56
- No Code Available26
- Unspecified Infection14
- Pain13
- Joint Laxity11
- Not Applicable6
- Test Result5
- Foreign Body Reaction3
Recent adverse event reports
The 25 most recent of 93 reports, in the reporter's own words as published by the FDA.
InjuryJul 27, 2026Device Dislodged or Dislocated
It was reported that the patient was revised due to dislocated left total hip. Revised cup to Emphasys cup with dual mobility.DOI: (b)(6)2026.DOR: (b)(6)2026.Affected side: Left hip.
Patient problems: Joint Dislocation
MAUDE report 50036504 ↗InjuryApr 9, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT HAD A TOTAL HIP PLACED ON THE ABOVE LISTED DATE FOR CROWE 4 HIP DYSPLASIA. UNFORTUNATELY, PATIENT DISLOCATED HIP ON POST OP DAY 1 AND WAS BROUGHT BACK TO THE OR FOR A HIP REVISION. SURGEON BELIEVES THAT THE CHOSEN ANTEVERSION THAT WAS SELECTED AT THE INDEX PROCEDURE WAS TOO GREAT AND THE FEMORAL COMPONENT WAS REVISED ACCORDINGLY. ONCE PLACED, SURGEON WAS STILL CONCERNED WITH HOW QUICKLY PATIENT HAD DISLOCATED POSTOPERATIVELY AND CHOSE TO ALSO CHANGE THE LINER TO AN ELEVATED RIM LINER TO FURTHER ENHANCE STABILITY. A FRACTURE OF THE GREATER TROCHANTER OCCURRED DURING THE INDEX PROCEDURE AND WAS TREATED WITH A TROCHANTERIC PLATE, INCLUDING CABLES AND A SCREW FOR STABILIZATION. NO DELAY AND NO PATIENT HARM WAS NOTED. AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Dislocation; Joint Laxity
MAUDE report 24831557 ↗InjuryMar 30, 2026Device Dislodged or Dislocated
ADDITIONAL INFORMATION RECEIVED: A. KINDLY CONFIRM THE CONSTRUCT REMOVED ON (B)(6) 2026 WERE DEPUY IMPLANTS. - SURGEON CONFIRMED THE CONSTRUCT REMOVED ON (B)(6) 2026 WERE DEPUY IMPLANTS.
Patient problems: Joint Dislocation
MAUDE report 24726779 ↗InjuryMar 11, 2026Device Dislodged or Dislocated
PATIENT WAS REVISED WITH POLY AND HEAD EXCHANGE DUE TO DISLOCATION. THERE WAS NO SURGICAL DELAY AND NO HARM TO PATIENT. NO BROKEN INSTRUMENT WAS REPORTED. DOI: (B)(6) 2019. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Dislocation
MAUDE report 24570154 ↗InjuryFeb 19, 2026Naturally Worn; Noise, Audible
IT WAS REPORTED THAT THE PATIENT PRESENTED WITH NOISY HIP, AFTER X-RAYS IT WAS NOTED THAT THE POLYETHYLENE LINER HAD MOVED AND THE CERAMIC HEAD WAS WEARING ON THE METAL CUP.
Patient problems: Insufficient Information
MAUDE report 24391188 ↗InjuryFeb 5, 2026Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED DUE TO INSTABILITY. DOI: UNKNOWN, DOR: (B)(6) 2026, AFFECTED SIDE: UNKNOWN HIP.
Patient problems: Joint Laxity
MAUDE report 24266071 ↗InjuryNov 21, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT EXPERIENCED DISLOCATION. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Dislocation
MAUDE report 23617237 ↗InjuryNov 17, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE CUP MOVED CAUSING HIP TO DISLOCATE AND PULLING CONSTRAINED LINER OUT OF THE CUP. THIS PATIENT HAS HAD MULTIPLE HIP REVISIONS ON THIS HIP. AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Dislocation
MAUDE report 23570239 ↗InjurySep 2, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT HAD HIP DISLOCATION. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN HIP.
Patient problems: Joint Dislocation
MAUDE report 22938638 ↗InjurySep 2, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION. AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Dislocation
MAUDE report 22936655 ↗InjuryAug 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED FOR CERAMIC HEAD AND POLY LINER EXCHANGE BECAUSE OF INFECTION. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: UNKNOWN HIP.
Patient problems: Unspecified Infection
MAUDE report 22744382 ↗InjuryJul 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT WAS INFECTED AND SURGEON PERFORMED A HIP I&D WITH HEAD/LINER EXCHANGE. THERE WERE NO DELAYS OR COMPLAINTS. AFFECTED SIDE: LEFT HIP.
Patient problems: Unspecified Infection
MAUDE report 22385630 ↗InjuryJun 17, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT HAD CHRONIC DISLOCATION. PATIENT EXPERIENCED BACK FUSION A FEW YEARS AFTER TOTAL HIP REPLACEMENT. AFFECTED SIDE: UNKNOWN HIP SIDE.
Patient problems: Joint Dislocation
MAUDE report 22230369 ↗InjuryMay 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD A HEAD AND LINER EXCHANGE DUE TO INFECTION. DOI: UNK. DOR: (B)(6) 2025. AFFECTED AREA: LEFT HIP.
Patient problems: Unspecified Infection
MAUDE report 22062524 ↗InjuryMay 6, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE PATIENT WAS REVISED DUE TO DISLOCATION FROM CONSTRAINED LINER. NEW LINER AND HEAD WERE PLACED. UNKNOWN SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Dislocation
MAUDE report 21971293 ↗InjuryFeb 26, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
PATIENT WAS REVISED DUE TO DISLOCATION. SO THE LINER WAS SWAPPED. AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Dislocation
MAUDE report 21472786 ↗InjuryDec 6, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO SURGICAL DELAY.
Patient problems: Joint Dislocation
MAUDE report 20871856 ↗InjuryDec 3, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT : B. WAS THERE ANY PATIENT CONSEQUENCES DUE TO REPORTED EVENT? NOT DUE TO OUR IMPLANTS. C. WAS THERE ANY SURGICAL DELAY RELATED TO EVENT? NO. E. IS THERE ANY OTHER INCIDENT RECORDED BEFORE FOR THE MULTIPLE DISLOCATION? IF YES THEN PLEASE PROVIDE THE COMPLAINT OR IS ANY REVISION OCCURRED BEFORE THEN PLEASE PROVIDE THE DETAILS. NO.
Patient problems: Joint Dislocation
MAUDE report 20832707 ↗InjuryNov 19, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT WAS CHRONICALLY DISLOCATING, DOCTOR CHANGED OUT THE CUP/LINER AND HEAD TO A BETTER POSITIONED CUP AND A CONSTRAINED LINER. DOI: UNKNOWN. DOR: UNKNOWN. AFFECTED SIDE: UNKNOWN HIP SIDE.
Patient problems: Joint Dislocation
MAUDE report 20726056 ↗InjurySep 5, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT KEEPS DISLOCATING AND GOING TO REPLACE THE LINER TO A CONSTRAINED LINER. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Dislocation
MAUDE report 20152514 ↗InjuryJul 15, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
PATIENT WAS REVISED DUE TO DISLOCATION TWICE. DOI: UNKNOWN DOR: (B)(6) 2024 AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Dislocation
MAUDE report 19741216 ↗InjuryJun 19, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO FELL AND DISLOCATED HIP. IT WAS REVISING TO A CONSTRAINED LINER. IT WAS UNKNOWN WHETHER THERE WAS ANY LOOSENING. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.
Patient problems: Fall; Joint Dislocation
MAUDE report 19567491 ↗InjuryMay 13, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT DISLOCATED WHILE IN A SEATED POSITION AND WAS CHRONICALLY UNSTABLE. A PRIOR REVISION SURGERY WAS PERFORMED AT THE HOSPITAL ON (B)(6) 2024 AND AN MDR WAS SUBMITTED. THE PRIMARY SURGERY WAS PERFORMED AT THE HOSPITAL ON (B)(6) 2017 AND CONVERTED TO DUAL MOBILITY. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Dislocation; Joint Laxity
MAUDE report 19301674 ↗InjuryMar 1, 2024Device Dislodged or Dislocated; Noise, Audible; Device Dislodged or Dislocated; Noise, Audible
HCP REPORTED TWO CONSECUTIVE REVISIONS OF HIP PE-INLAYS. THIS COMPLAINT IS ABOUT THE SECOND REVISION. PATIENT WAS LIFTING HEAVY CEMENT BAGS AND HAD PAIN AND SQUEAKING IN LEFT HIP. XRAYS SHOW HIP HEAD IS OFF CENTER AND SUSPECT DISLOCATION. DURING THE REVISION, OSTEOPHYTES ALONG THE ¿SOCKET EDGE¿ WERE IDENTIFIED ALONG WITH METALLOSIS, A HEAD/LINER DISLOCATION AND FRACTURED INLAY. DOI: (B)(6) 2023. DOR: (B)(6) 2023.
Patient problems: Foreign Body Reaction; Joint Dislocation; Pain; Unspecified Musculoskeletal problem
MAUDE report 18815712 ↗InjuryFeb 28, 2024Device Dislodged or Dislocated; Noise, Audible; Device Dislodged or Dislocated; Noise, Audible
ON (B)(6) 2023 PATIENT DESCRIBES A BOTHERSOME CLUNKING NOISE IN RIGHT HIP AND ON (B)(6) 2023: PATIENT STATES SHE IS IN PAIN. NO INDICATION WHERE PAIN IS OR INTERVENTIONS PROVIDED. DOI: (B)(6) 2022; DOR: UNREVISED; RIGHT HIP.
Patient problems: Joint Dislocation; Pain
MAUDE report 18798784 ↗
Other Prosthesis, hip, semi-constrained (metal uncemented acetabular component) devices
- RingLoc® Hip System 103531Biomet Orthopedics, LLC · Prosthesis, hip, semi-constrained (metal uncemented acetabular component)1 recall0 reports
- BIOLOX DELTA 1365-28-710Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained (metal uncemented acetabular component)43 reports
- ASPHERE 1365-52-100Depuy (Ireland) · Prosthesis, hip, semi-constrained (metal uncemented acetabular component)39 reports
- ASPHERE 1365-05-100Depuy (Ireland) · Prosthesis, hip, semi-constrained (metal uncemented acetabular component)29 reports
- ASPHERE 1365-06-100Depuy (Ireland) · Prosthesis, hip, semi-constrained (metal uncemented acetabular component)29 reports
- Taperloc Complete Micro Primary Femoral 51-107130Biomet Orthopedics, LLC · Prosthesis, hip, semi-constrained (metal uncemented acetabular component)23 reports
- Taperloc Complete Micro Primary Femoral 51-107120Biomet Orthopedics, LLC · Prosthesis, hip, semi-constrained (metal uncemented acetabular component)19 reports
- ASPHERE 1365-53-100Depuy (Ireland) · Prosthesis, hip, semi-constrained (metal uncemented acetabular component)18 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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