BIOLOX DELTA 1365-32-230Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10603295033424), received between Jul 21, 2017 and Mar 4, 2026 — classified as 17 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (10 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryMar 4, 2026Device Dislodged or Dislocated

  ADDITIONAL INFORMATION RECEIVED: A. KINDLY CONFIRM IS THERE ANY ALLEGATION AGAINST THE CUP? - NO ALLEGATIONS ON ANY IMPLANT.

  Patient problems: Joint Dislocation

  MAUDE report 24506537 ↗
• InjuryJun 18, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED AND SURGEON EXPLANTED DUE TO DISLOCATION. THE HEAD DISLOCATED FROM THE CONSTRAINED LINER. NO REPLACEMENTS ARE NEEDED. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Joint Dislocation

  MAUDE report 22286322 ↗
• InjuryNov 15, 2024Fracture; Fracture

  IT WAS REPORTED, THAT THE SURGEON REVISED A 18X13 30+4 S-ROM STEM AND A 50MM PINNACLE CUP. THE PINNACLE CUP WAS DETERMINED, TO BE IMPLANTED TOO FLAT AND ANTEVERTED, DURING A PREVIOUS OPERATION, WHICH HAD LED TO THE 32MM +6 CERAMIC BREAKING. THE S-ROM STEM WAS EXPLANTED AND A 18X13 36+12 STEM WAS IMPLANTED. THE CUP WAS EXPLANTED AND A 58MM REVISION CUP WITH A 36MM CERAMIC HEAD WAS IMPLANTED. THERE WAS NO SURGICAL DELAY. THE NEW STEM PROVIDED GOOD STABILITY. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 20693867 ↗
• InjuryAug 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REVISED DUE TO INSTABILITY, NEW HEAD IMPLANTED. NO FURTHER INFORMATION AVAILABLE. THERE WAS NO REPORTED LOOSENING. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 15312609 ↗
• InjuryMay 5, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO THE DISLOCATION OF HEAD AND LINER AND WERE REPLACED. NEW 28 HEAD 958840 BROKE WHEN REMOVING. UNKNOWN IF ANY LOOSENING. UNKNOWN IF ANY SURGICAL DELAY. DOI: (B)(6) 2020; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 14287775 ↗
• InjuryOct 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED FOR INSTABILITY. DOI: UNKNOWN, DOR: (B)(6) 2021, AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 12565088 ↗
• InjuryMay 13, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES DISLOCATION AFTER FIRST REVISION. DOI: (B)(6) 2011 - DOR: NONE REPORTED (LEFT HIP). PLEASE SEE (B)(4) FOR THE FIRST SECOND EVENT.

  Patient problems: Joint Dislocation

  MAUDE report 8603460 ↗
• InjuryApr 10, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  LITIGATION ALLEGES DISLOCATION WITH CLOSED REDUCTION. DOI: (B)(6) 2013. DOR: (B)(6) 2014 (LEFT HIP).

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8499700 ↗
• InjuryApr 2, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGED DISLOCATION AFTER FIRST REVISION.

  Patient problems: Joint Dislocation

  MAUDE report 8473456 ↗
• InjuryJan 16, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF ALLEGES DISLOCATION WITH CLOSED REDUCTION AFTER FIRST REVISION.

  Patient problems: Joint Dislocation

  MAUDE report 8253190 ↗
• InjuryJul 25, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS DISLOCATION. IT WAS ALSO INDICATED THAT THE PATIENT HAD A DEPUY SROM PRIMARY STEM AND ZTT2 SHELL IMPLANTED. THE SURGEON REMOVE THE SHELL, LINER AND HEAD. DOI: UNKNOWN; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Joint Dislocation; Not Applicable

  MAUDE report 7719154 ↗
• InjuryJun 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DER STATES THAT THIS PATIENT HAD HER RIGHT HIP REPLACED RECENTLY AND WEEKS AFTER BEGAN TO HAVE SOME DRAINAGE FROM HER WOUND. SHE HAD A CONSULTATION AND HIP ASPIRATION WHICH INDICATED THERE WAS MOST LIKELY AN INFECTION PRESENT. SURGEON BROUGHT THE PATIENT TO WILLIAM BEAUMONT TROY FOR AN I&D PROCEDURE. THE HIP BALL, STEM, AND LINER WAS EXPLANTED. THE 48MM SECTOR CUP AND SROM SLEEVE WAS LEFT IMPLANTED. THE WOUND AND JOINT WAS WASHED OUT AND NEW COMPONENTS WERE IMPLANTED. DOI: (B)(6) 2018; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Not Applicable; Unspecified Infection

  MAUDE report 7609196 ↗
• InjuryJun 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION. REMOVED ALL PARTS AND PUT SPACER IN. DOI: UNKNOWN; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Not Applicable; Unspecified Infection

  MAUDE report 7597363 ↗
• InjuryFeb 5, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT COMPLAINED OF THIGH PAIN, NO LOOSENING. ORIGINAL SURGERY DONE IN 2015. NO AVAILABLE RECORDS. REMOVED HEAD, STEM, SLEEVE, LINER AND TWO BONE SCREWS. NO SURGICAL DELAY. NO BROKEN INSTRUMENTS. PATIENT CONSEQUENCE? :UNKNOWN.

  Patient problems: Pain

  MAUDE report 7240647 ↗
• InjuryNov 3, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY AND CHRONIC DISLOCATIONS. HEAD & LINER WERE EXCHANGED. STEM & SLEEVE REMAIN IN SITU.

  Patient problems: Joint Dislocation

  MAUDE report 6999106 ↗
• InjurySep 8, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS DISLOCATION. UPDATE 8-9-2017: MEDICAL RECORDS HAVE BEEN REVIEWED. OPERATIVE NOTES (B)(6)2017 INDICATE THE PATIENT RECEIVED A REVISION RIGHT TOTAL HIP ARTHROPLASTY WITH HEAD AND POLY EXCHANGE, SCREW REMOVAL AND GRAFTING OF OSTEOLYTIC DEFECTS. THIS DOES NOT AFFECT MDR REPORTABILITY.

  Patient problems: Joint Dislocation

  MAUDE report 6851700 ↗
• InjuryJul 21, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  EVENT REPORT STATED THAT PATIENT REPORTED SYMPTOMS OF EXTREME PAIN AND AMBULATION DIFFICULTIES. PATIENT HAS AN ALLERGY TO NICKEL AND VANADIUM.

  Patient problems: Pain

  MAUDE report 6732393 ↗