BIOLOX DELTA 1365-36-330Recalls & reported problems
Depuy Orthopaedics, Inc. · BIOLOX DELTA CERAMIC FEMORAL HEAD +8.5 36mm DIA 12/14 TAPER · 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 the ball part of a hip replacement. Its 255 reports often describe infections and hip dislocations after surgery, with some mentioning parts catching against each other and revision surgery. There were no deaths and 244 injuries. 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
- 255
- Deaths reported
- 0
- Injuries reported
- 244
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 255 adverse event reports that list this exact device (DI 10603295033639), received between Jul 19, 2017 and Sep 17, 2026 — classified as 244 injuries, 11 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (59 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 Problem163
- Device Dislodged or Dislocated59
- Insufficient Device Problem Information15
- Difficult to Insert4
- Naturally Worn4
- Noise, Audible3
- Difficult to Open or Remove Packaging Material2
- Fracture2
Patient problems
- Unspecified Infection103
- No Code Available63
- Joint Dislocation60
- Pain45
- Joint Laxity15
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available12
- Insufficient Information10
- Tissue Damage8
Recent adverse event reports
The 25 most recent of 255 reports, in the reporter's own words as published by the FDA.
InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem
It was reported that washout due to infection. Head and liner removal and reimplantation of same sizes. Affected side: Right hip.
Patient problems: Unspecified Infection
MAUDE report 50805755 ↗InjuryAug 26, 2026Adverse Event Without Identified Device or Use Problem
It was reported that infected wash out and head/liner exchange.Affected Side: Left.
Patient problems: Unspecified Infection
MAUDE report 50459384 ↗InjuryAug 26, 2026Device Dislodged or Dislocated
It was reported that the patient was dislocating so the doctor revised the hip. No delay in surgery. No known infection present. Original surgical date was on (b)(6) 2026.Affected side-Left.
Patient problems: Joint Dislocation
MAUDE report 50453553 ↗InjuryAug 19, 2026Device Dislodged or Dislocated
It was reported that Patient showed up to the ER according to the surgeon. X-ray shows hip was dislocated.Affected side-Left.
Patient problems: Joint Dislocation
MAUDE report 50320649 ↗InjuryJun 16, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A DISLOCATED HIP FOLLOWING A FALL AFTER AATHA. REVISED HEAD AND LINER. AFFECTED SIDE: RIGHT HIP.
Patient problems: Fall; Joint Dislocation
MAUDE report 25522225 ↗InjuryJun 3, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2019. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT.
Patient problems: Pain
MAUDE report 25374341 ↗InjuryMay 20, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT HAD INFECTED HIP. IMPLANTS WERE REMOVED AND TEMPORARY SPACER IMPLANTED. THERE WERE NO DELAYS, COMPLAINTS, AND NO HARM TO THE PATIENT. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.
Patient problems: Unspecified Infection
MAUDE report 25234073 ↗InjuryApr 29, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT IT HAD BEEN REVISED FOR A DISLOCATION. DOI: (B)(6) 2026, DOR: (B)(6) 2026, AFFECTED SIDE-LEFT HIP.
Patient problems: Joint Dislocation
MAUDE report 25035302 ↗InjuryApr 28, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT HEAD LINER EXCHANGE DUE TO INFECTION, THERE WAS NO HARM DONE TO THE PATIENT, THERE WAS NO DELAY IN CASE, NO PRODUCT COMPLAINTS. ORIGINAL IMPLANTATION DATE (B)(6) 2025. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 25020821 ↗InjuryApr 27, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT HAD A LEFT TOTAL HIP DONE BY SURGEON IN (B)(6) 2024. PATIENT CAME IN WITH A HIP INFECTION AND REMOVAL OF IMPLANTS AND ANTIBIOTIC SPACER WAS IMPLANTED. AFFECTED SIDE: LEFT HIP.
Patient problems: Unspecified Infection
MAUDE report 24999801 ↗InjuryApr 15, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT PATIENT CHRONICALLY DISLOCATING. AFFECTED SIDE-RIGHT HIP.
Patient problems: Joint Dislocation
MAUDE report 24885285 ↗InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO HIP INFECTION POLY WAS EXCHANGE. AFFECTED SIDE: LEFT HIP.
Patient problems: Unspecified Infection
MAUDE report 24872051 ↗InjuryApr 7, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT PATIENT HAD A DISLOCATION SO THE SURGEON OPTED TO TAKE OUT THE LINER AND HEAD TO USE A DUAL MOBILITY CONSTRUCT. NO PATIENT COMPLICATIONS DURING CASE. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.
Patient problems: Joint Dislocation
MAUDE report 24802476 ↗InjuryMar 23, 2026Adverse Event Without Identified Device or Use Problem
PATIENT WAS WASHOUT FOR INFECTION. EXPLANTED THE ALTRX 60X36 LINER, THE HOLE ELIMINATOR, AND 36 BIOLOX DELTA HEAD. WASHOUT WAS CONDUCTED AND NEW HOLE ELIMINATOR, 60 ALTRX LINER AND A 36 + 8.5 COBALT CHROME HEAD WAS IMPLANTED. NO DELAY IN SURGERY. NO INJURY TO PATIENT. DOI: (B)(6) 2024. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT.
Patient problems: Unspecified Infection
MAUDE report 24661710 ↗InjuryMar 6, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT HEAD AND LINER CHANGE AFTER IRRIGATION AND DEBRIDEMENT. THERE WAS NO ALLEGATION AGAINST IMPLANTS. THERE WAS NO WAY TO CONFIRM INFECTION. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.
Patient problems: Insufficient Information; Unspecified Infection
MAUDE report 24535689 ↗InjuryFeb 26, 2026Improper or Incorrect Procedure or Method
IT WAS REPORTED THAT THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2026 AND 52 CUP; 32X52 LINER, 36MM HEAD WERE ALL IMPLANTED. POSTOPERATIVE REVIEW OF X-RAYS REVEALED THAT THE HEAD DID NOT APPEAR TO BE PROPERLY SEATED, AND IT WAS DETERMINED THROUGH THE IMPLANT LOG THAT AN INCORRECT HEAD HAD BEEN IMPLANTED. A REVISION SURGERY WAS PERFORMED TO REPLACE THE HEAD AND LINER WITH THE CORRECT SIZES. DOI: (B)(6) 2026. DOR: (B)(6) 2026. AFFECTED SIDE: UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 24457160 ↗InjuryFeb 12, 2026Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION RECEIVED: A. WHAT IS THE AFFECTED SIDE INVOLVED IN THIS EVENT? LEFT. B. PLEASE CONFIRM IF THE FEMORAL HEAD AND ACETABULAR CUP FRACTURED OR IF THIS WAS AN ACETABULAR BONE FRACTURE. BONY FRACTURE, NOT IMPLANT.
Patient problems: Joint Laxity
MAUDE report 24327016 ↗InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD AN IRRIGATION AND DEBRIDEMENT(I&D). AFFECTED SIDE: RIGHT HIP.
Patient problems: Insufficient Information
MAUDE report 24304148 ↗InjuryFeb 2, 2026Adverse Event Without Identified Device or Use Problem
WHAT IS THE EXACT ALLEGATION OF THE REPORTED PRODUCT? THERE WAS NO ALLEGATION. PRODUCTS WERE REMOVED TO CONDUCT AN I&D DUE TO SUSPECTED INFECTIONS.
Patient problems: Unspecified Infection
MAUDE report 24236316 ↗InjuryJan 8, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO INFECTION OF THE HIP. HEAD AND LINER WERE EXTRACTED AND REPLACED WITH IMPLANTS. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 24012212 ↗InjuryJan 6, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DUE TO INFECTION, SURGEON WANTED TO SWAP HEAD AND LINER. NO ALLEGATIONS AGAINST PRODUCTS. AFFECTED SIDE: LEFT HIP.
Patient problems: Unspecified Infection
MAUDE report 23978076 ↗InjuryJan 5, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT FELL AND BROKE HER HIP IN JUNE. A TOTAL HIP WAS DONE. PATIENT HAD A LINER AND HEAD REVISION ON (B)(6) 2025 BECAUSE PATIENT DISLOCATED MULTIPLE TIMES. SOMEWHERE BETWEEN (B)(6) 2025 THE PATIENT DISLOCATED AGAIN. PATIENT WAS NOT AT THE HOSPITAL FOR HIP PAIN BUT THEY TOOK AN X RAY ANYWAY AND FOUND IT TO BE DISLOCATED. PATIENT ALSO HAD WHAT WAS BELIEVED TO BE A SINUS TRACK ON HER SCAR SO THE DOCTOR DECIDED TO DO AN EXPLANT WITH GIRDLE STONE. DOI: (B)(6) 2025 DOR: (B)(6), 2025 AFFECTED SIDE: RIGHT HIP. (B)(4) CAPTURES THE FIRST DISLOCATION REVISION AND (B)(4) CAPTURES THE SECOND DISLOCATION AND THE GIRDLE STONE PROCEDURE.
Patient problems: Joint Dislocation
MAUDE report 23968063 ↗InjuryDec 29, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THE PATIENT EXPERIENCED A DISLOCATED HIP DUE TO INSTABILITY. THE LINER AND HEAD WERE REPLACED TO REGAIN STABILITY.
Patient problems: Joint Dislocation; Joint Laxity
MAUDE report 23906241 ↗InjuryDec 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2020. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.
Patient problems: Pain
MAUDE report 23845371 ↗InjuryDec 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO CHRONICAL INFECTION. SURGEON REMOVED IMPLANTS AND DID PLACEMENT OF A TEMPORARY SPACER UNTIL HEALING. AFFECTED SIDE: LEFT HIP.
Patient problems: Unspecified Infection
MAUDE report 23773667 ↗
Other Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented devices
- BIOLOX DELTA 1365-36-310Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented839 reports
- BIOLOX DELTA 1365-36-320Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented643 reports
- PINNACLE POROCOAT 1217-22-052Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented335 reports
- PINNACLE POROCOAT 1217-22-054Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented263 reports
- PINNACLE POROCOAT 1217-22-050Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented253 reports
- PINNACLE POROCOAT 1217-22-056Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented220 reports
- SUMMIT POROCOAT 1570-11-120Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented1 death204 reports
- SUMMIT POROCOAT 1570-11-135Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented186 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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