BIOLOX DELTA 1365-36-720Recalls & reported problems

Summary

The FDA's MAUDE database contains 189 adverse event reports that list this exact device (DI 10603295033660), received between Oct 12, 2016 and Sep 10, 2026 — classified as 1 death, 187 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (75 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 189 reports, in the reporter's own words as published by the FDA.

• InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient was revised due to pain.DOI: Unknown.DOR:(b)(6) 2026.Affected Side: Left.

  Patient problems: Pain

  MAUDE report 50717122 ↗
• InjuryAug 18, 2026Device Dislodged or Dislocated

  It was reported that the patient was revised due to Dislocation.Affected side: Unknown.

  Patient problems: Joint Dislocation

  MAUDE report 50298126 ↗
• InjuryJul 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED AN UNSTABLE HIP. DOI: UNKNOWN, DOR: ON (B)(6) 2026, AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 25827971 ↗
• InjuryJun 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS BEING REVISED DUE TO INSTABILITY. DR. REMOVED THE EMPHASYS NUETRAL LINER AND THE 36MM +5 HEAD. HE TRIALED WITH A 36 +4 NEUTRAL LINER ABD AND A 36 +8.5 HEAD. THE HIP WAS VERY STABLE SO HE IMPLANTED THOSE PARTS. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT.

  Patient problems: Joint Laxity

  MAUDE report 25637437 ↗
• InjuryApr 8, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT HAS HAD MULTIPLE REVISIONS, AFTER A REVISION ON (B)(6) 20/26. THE PATIENT DISLOCATED. THE CUP WAS REVISED AND A DUAL MOBILITY WAS IMPLANTED WITHOUT INCIDENT. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 24818959 ↗
• InjuryFeb 19, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT HAD CHRONIC DISLOCATION; CONVERTED TO CONSTR LINER. AFFECTED SIDE- RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 24387812 ↗
• InjuryFeb 9, 2026Naturally Worn

  PATIENT WAS REVISED DUE TO HEAD AND LINER EXCHANGE FOR POLY WEAR. SURGEON REPORTED THAT PATIENT WAS IN PAIN AND HAD LIMITED RANGE OF MOTION. UPON EXPLANT, SIGNIFICANT POLY WEAR WAS EXPERIENCED. THERE WAS TRANSFER DEBRIS ON THE HEAD FROM ARTICULATING IN THE CUP (WAS BLACK). NEW LINER WAS SEATED INTO CUP ADEQUATELY. NEW HEAD WAS IMPLANTED. DOI: (B)(6) 2011. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 24291248 ↗
• InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT LINER & HEAD WERE REMOVED DUE TO INFECTION. DOI: (B)(6) 2024, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT.

  Patient problems: Unspecified Infection

  MAUDE report 24215236 ↗
• InjuryDec 26, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT HAD PREVIOUS HIP REVISION DUE TO METALLOSIS. METAL LINER AND HEAD WERE REMOVED AND THOROUGH WASHOUT IN PREVIOUS SURGERY. OVER THE LAST FIVE TO SIX MONTHS PATIENT HAS HAD CHRONIC ISSUES WITH DISLOCATIONS. NEW REVISION CONVERTING HIP TO DUAL MOBILITY WAS DETERMINED TO BE NEEDED TO SOLVE PATIENT DISLOCATIONS. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP. THIS REPORT CAPTURES THE SURGERY NEEDED DUE TO DISLOCATIONS IS CAPTURED. THE OTHER REVISION TO ADDRESS THE METALLOSIS IS CAPTURED ON RELATED COMPLAINT (B)(4).

  Patient problems: Joint Dislocation

  MAUDE report 23895945 ↗
• InjuryDec 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain

  MAUDE report 23887772 ↗
• InjurySep 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR INSTABILITY DUE TO FRACTURE. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 23019995 ↗
• InjurySep 9, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO CHRONIC DISLOCATION. DOI: (B)(6), 2024. DOR: (B)(6), 2025. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 23005336 ↗
• InjuryJul 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED AND UNDERWENT AN INFECTED HIP WASHOUT WITH ACETABULAR LINER AND FEMORAL HEAD SWAP. DOI: (B)(6) 2025 DOR: (B)(6) 2025 AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22648906 ↗
• InjuryJul 28, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE POLY SHOWED DAMAGED FROM IMPINGEMENT POSTERIORLY. PATIENT ALSO EXPERIENCED DISLOCATION. REVISION WAS PERFORMED. REVISED TO A DUAL MOBILITY AND CHANGED THE CUP POSITION. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 22628794 ↗
• InjuryMay 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT WAS REVISED DUE TO PAIN. AFFECTED AREA: UNKNOWN HIP.

  Patient problems: Pain

  MAUDE report 22062004 ↗
• InjuryMay 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT HIP I & D PERFORMED. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 22015189 ↗
• InjuryFeb 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED: WAS/WERE THERE ANY ADVERSE CONSEQUENCE/S THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? NO.

  Patient problems: Unspecified Infection

  MAUDE report 21364028 ↗
• InjuryFeb 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A REVISION OF ALL THE IMPLANTS DUE TO INFECTION. UNKNOWN SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 21345717 ↗
• InjuryFeb 7, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT WAS DISLOCATING. SURGEON PLACED LONGER TS CERAMIC HEAD FOR STABILITY. CUP, LINER, AND STEM ALL REMAINED IN PATIENT. ONLY THE HEAD WAS CHANGED. THERE WERE NO KNOWN SURGICAL DELAYS. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 21333402 ↗
• InjuryJan 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A DISLOCATING RIGHT TOTAL HIP DONE BY THE SURGEON. THE ORIGINAL HIP WAS DONE (B)(6) 2024. IT WAS REVISED THE FIRST TIME ON (B)(6) 2024 WHERE JUST THE FEMORAL HEAD WAS EXCHANGED. IN THE CURRENT REVISION NOW, THE SURGEON EXCHANGED BOTH THE HEAD AND LINER TO A CONSTRAINED CONSTRUCT. THE ACETABULAR CUP AND FEMORAL STEM WERE WELL FIXED AND RETAINED. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 21056748 ↗
• InjuryDec 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS WERE REMOVED DUE TO INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 20870352 ↗
• InjurySep 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED: NO DELAY.

  Patient problems: Unspecified Infection

  MAUDE report 20266881 ↗
• InjurySep 3, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE LINER DISASSOCIATED FROM THE CUP ON TWO SEPARATE OCCASIONS , ORIGINAL SURGERY ON (B)(6) 2022 . LINER EXCHANGED ON (B)(6) 2023 , CUP REVISED ON (B)(6) 2024. DOI: (B)(6) 2023 DOR: (B)(6) 2024 AFFECTED SIDE : RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 20123983 ↗
• InjuryAug 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI- (B)(6), 2024. DOR- (B)(6) 2024. AFFECTED SIDE- UNKNOWN HIP.

  Patient problems: Joint Laxity

  MAUDE report 20087028 ↗
• InjuryMar 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAINFUL LEFT HIP. THERE WAS NO ADDITIONAL INFORMATION. DOI: (B)(6) 2021. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain

  MAUDE report 18836776 ↗