BIOLOX DELTA 1365-40-730Recalls & reported problems

Summary

The FDA's MAUDE database contains 117 adverse event reports that list this exact device (DI 10603295033714), received between Jan 12, 2018 and Sep 1, 2026 — classified as 115 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (37 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 117 reports, in the reporter's own words as published by the FDA.

• InjurySep 1, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient underwent revision surgery for an infected hip. The surgeon changed the cup liner and the femoral head. The acetabular cup was not revised.DOI: (b)(6) 2026,DOR: (b)(6) 2026,Affected side: Right Side

  Patient problems: Unspecified Infection

  MAUDE report 50545869 ↗
• InjuryJun 24, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT HEAD AND LINER WAS EXCHANGED DUE TO DISLOCATION. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 25612355 ↗
• InjuryJun 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD FALLEN AND OPENED UP IN THE INCISION, SO DOCTOR HAD WANTED TO EXCHANGE COMPONENTS. THE ORIGINAL SURGERY HAD BEEN DONE 2 WEEKS EARLIER. NO FURTHER INFORMATION WAS AVAILABLE. AFFECTED SIDE-LEFT HIP.

  Patient problems: Fall; Wound Dehiscence

  MAUDE report 25471606 ↗
• InjuryJun 8, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INSTABILITY OF THE HIP AND HAD TWO DISLOCATIONS. NO ALLEGATION AGAINST THE CUP. DOI: (B)(6) 2026. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 25427738 ↗
• InjuryMay 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT INFECTED HIP, WASHOUT POLY AND HEAD EXCHANGE. DOI-UNKNOWN. DOR-UNKNOWN. AFFECTED SIDE-LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 25331045 ↗
• InjuryApr 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT I&D HEAD AND LINER WERE EXCHANGE. AFFECTED SIDE-RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 24884434 ↗
• InjuryMar 19, 2026Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: THE PATIENT HAD BEEN ADMITTED SHOWING THE INITIAL STAGES OF AN INFECTION FOLLOWING A PRIMARY HIP ARTHROPLASTY PERFORMED THE MONTH PRIOR. IN ORDER TO EFFECTIVELY TREAT THE INFECTION, AN OPEN DEBRIDEMENT AND WASHOUT WAS PERFORMED. IN ORDER TO HAVE GOOD EXPOSURE OF THE SURGICAL SITE, THE MODULAR FEMORAL HEAD WAS REMOVED. A FRESH MODULAR FEMORAL HEAD WAS IMPLANTED UPON COMPLETION OF THE WASH OUT. THERE ARE NO KNOWN PATIENT CONSEQUENCES AS A RESULT OF THIS PROCEDURE, NOR RESULTING FROM THE FUNCTIONALITY/STABILITY/QUALITY OF THE DEPUY SYNTHES PROSTHESIS, NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 24641376 ↗
• InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025 THE PATIENT HAD NATIVE INFECTED HIP. A SPACER WAS PLACED TO TREAT INFECTION. PATIENT WAS INFECTED AGAIN SO THE SPACER WAS REMOVED ON (B)(6) 2025. A NEW SPACER WAS PLACED ON THIS DATE. AFFECTED SIDE-UNKNOWN HIP.

  Patient problems: Unspecified Infection

  MAUDE report 24034808 ↗
• InjuryNov 20, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION. DOI-UNKNOWN. DOR-(B)(6) 2025. AFFECTED SIDE-RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 23609238 ↗
• InjuryNov 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6) STUDY NO: OASIS PROD. CLINICAL ADVERSE EVENT RECEIVED FOR REVISION ¿ INFECTION DEVICE AND PROCEDURE (RELATEDNESS), DEVICE RELATED: NO INFORMATION PROVIDED, PROCEDURE RELATED: NO INFORMATION PROVIDED. DATE OF EVENT: 17 OCT 2025, DATE OF IMPLANT: (B)(6) 2025, DATE OF REVISION: (B)(6) 2025, DEVICE LOCATION: LEFT. TREATMENT/IMPACT: COMPONENTS REMOVED.(STEM, HEAD, LINER, SHELL) DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 121722058 LOT NUMBER: M9551X COMPONENT TYPE: SHELL DESCRIPTION: PINNACLE SHELL SECTOR 58MM. CATALOG NUMBER: 136540730 LOT NUMBER: 4549269 COMPONENT TYPE: HEAD DESCRIPTION: BIOLOX DELTA REVISION HEAD 12/14 40MM +8.5. CATALOG NUMBER: 101012070 LOT NUMBER: 4724370 COMPONENT TYPE: STEM DESCRIPTION: ACTIS COLLARED HIGH OFFSET FEMORAL STEM SZ 7. CATALOG NUMBER: 122140058 LOT NUMBER: M9976F COMPONENT TYPE: LINER DESCRIPTION: PINNACLE ALTRX 58MM X 40MM NEUTRAL. CATALOG NUMBER: 121730500 LOT NUMBER: PU236738 COMPONENT TYPE: SCREW DESCRIPTION: CANCELLOUS BONE SCREW 30MM.

  Patient problems: Unspecified Infection

  MAUDE report 23533956 ↗
• InjuryOct 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO I&D WITH HEAD AND LINER EXCHANGE FOR CONFIRMED INFECTION. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23362610 ↗
• InjuryOct 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD HARDWARE IN THEIR BACK, WAS FEELING LIKE THE HIP WASN'T STABLE. HEAD AND LINER WERE REMOVED AND DUAL MOBILITY WAS IMPLANTED. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 23339824 ↗
• InjuryAug 20, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO RECURRENT DISLOCATION. ACETABULAR REVISION WAS PERFORMED WITH COMPETITOR DEVICE. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 22849856 ↗
• InjuryAug 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. THEY DID A HEAD AND LINER EXCHANGE WITH A WASH OUT. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22840769 ↗
• InjuryJul 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED WITH REMOVAL OF HIP DUE TO INFECTION. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22481202 ↗
• InjuryJun 17, 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. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Pain

  MAUDE report 22229545 ↗
• InjuryJun 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE STAGE 2 REVISION DUE TO INFECTION. THERE WAS NO ISSUE WITH PRODUCTS AND NO TIME WASTED DUE TO PRODUCTS. DOI: (B)(6) 2024. DOR: UNKNOWN. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22123527 ↗
• InjuryApr 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DOCTOR WAS REVISED ALL THE IMPLANTS TO A CEMENT SPACER DUE TO AN ACTIVE INFECTION. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21909912 ↗
• InjuryApr 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED AS THE SURGEON PERFORMED HEAD/LINER EXCHANGE DUE TO INFECTION DURING HIP I&D. THERE WAS NO SURGICAL DELAY IN PROCEDURE OR COMPLAINTS. IMPLANTS ARE UNAVAILABLE FOR RETURN. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21902853 ↗
• InjuryApr 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A HEAD AND LINER EXCHANGE DUE TO INFECTION. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2025. DOR: (B)(6) 2025 AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21899411 ↗
• InjuryMar 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT CUP WAS REVISED DUE TO INSTABILITY. IT WAS NON-DEPUY CUP. THERE WAS NO IMPLANT FAILURE AND CASE DELAY. CUP WAS REVISED TO NON-DEPUY IMPLANT-DEPUY HEAD. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 21559206 ↗
• InjuryJan 22, 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 INFECTION. POLY AND HEAD EXCHANGE. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21210681 ↗
• InjuryJan 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO I&D LINER AND HEAD WERE CHANGED. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 21113861 ↗
• InjuryOct 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: A. PLEASE CONFIRM IF THE PREVIOUS 1ST STAGE REVISION INVOLVED DEPUY PRODUCTS. IF YES, PLEASE PROVIDE THE DETAILS. -YES IT INCLUDED DEPUY PRODUCT, ORIGINALLY REVISED FOR INFECTION. B. WHAT WAS THE REASON FOR REVISION. -NO. C. WAS THERE A SURGICAL DELAY? WHAT IS THE DURATION OF THE DELAY? -NO. D. WAS/WERE THERE ANY ADVERSE CONSEQUENCE/S THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? -NO.

  Patient problems: Unspecified Infection

  MAUDE report 20352097 ↗
• InjuryJul 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WAS NO SURGICAL DELAY.

  Patient problems: Unspecified Infection

  MAUDE report 19808500 ↗