BIOLOX DELTA 1365-28-220Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295033257), received between Nov 9, 2018 and Sep 9, 2025 — classified as 11 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjurySep 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Joint Laxity

  MAUDE report 23004952 ↗
• InjuryMay 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT ORIGINALLY HAD A HIP REPLACED IN (B)(6) 2024. THE PATIENT DEVELOPMENT AN INFECTION IN THE RIGHT HIP. ALL THE COMPONENTS WERE EXPLANTED AND REPLACED WITH A PROSTALAC STEM.

  Patient problems: Unspecified Infection

  MAUDE report 22084811 ↗
• InjuryNov 14, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION. UNKNOWN SURGICAL DELAY. DOI: UNKNOWN, DOR: (B)(6) 2024, AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 20688092 ↗
• InjuryApr 17, 2024No Apparent Adverse Event; No Apparent Adverse Event

  PATIENT WAS REVISED DUE TO FEMORAL HEAD FAILURE. DOI: (B)(6) 2018; DOR: (B)(6) 2024; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 19125788 ↗
• InjuryFeb 23, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION. THERE WAS NO SURGICAL DELAY. DOI- (B)(6) 2022. DOR- (B)(6) 2023. AFFECTED SIDE- RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 16428035 ↗
• InjuryDec 19, 2022Naturally Worn; Naturally Worn

  A PATIENT WITH AN SROM/PINNACLE BANTAM CONSTRUCT RETURNED FOR A REVISION HIP PROCEDURE AS A RESULT OF A DISASSOCIATED ALTRX LINER. THE CERAMIC FEMORAL HEAD IMPLANT WAS RUBBING AGAINST THE INSIDE OF THE PINNACLE SHELL.

  Patient problems: Insufficient Information

  MAUDE report 16003686 ↗
• InjuryDec 6, 2022Naturally Worn; Naturally Worn

  CORAIL PINNACLE WITH CERAMIC BEARINGS REVISED DUE TO UNKNOWN REASON OF OSTEOLYSIS. SOME MARKING WAS SEEN ON THE CUP AND HEAD, AND SOME BONE LOSS OBSERVED IN THE ACETABULUM AND FEMUR. REVISED TO AN S-ROM WITH G7 DUAL MOBILITY CUP, SURGEON WAS AWARE THAT THIS IS OFF LICENSE USAGE. NO PRODUCTS CODES ARE AVAILABLE FOR EXPLANTED IMPLANTS AS NO RECORDS. SURGEON DEEMED THAT THE CUP LOOKED STABLE, BUT THE STEM EXHIBITED SIGNS OF LOOSENING. RADIOGRAPHICALLY THESE LOOKED TO HAVE BEEN IMPLANTED IN THE CORRECT ORIENTATION. NO IMPLANTS ARE AVAILABLE AS THESE HAVE BEEN SENT TO ROYAL PERTH RETRIVALS.

  Patient problems: Osteolysis; Unspecified Tissue Injury

  MAUDE report 15924170 ↗
• InjuryJul 6, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENTS HIP DISLOCATED POST OP, NEXT DAY CUP WAS REMOVED AND VERSION WAS CHANGED. NEW SCREWS NEW LINER WERE IMPLANTED. DOI: (B)(6) 2021; DOR: (B)(6) 2021; UNKNOWN HIP.

  Patient problems: Joint Dislocation

  MAUDE report 12120808 ↗
• InjuryFeb 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AS PROSTALAC DUE TO INFECTION. SROM AND COMPETITORS CUP CONSTRUCT REMOVED AND REPLACED WITH A PROSTALAC. DOI: (B)(6) 2020, DOR: (B)(6) 2021, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11342562 ↗
• InjuryDec 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT COMPLAINTS OF A "FEELING OF INSTABILITY". HAD HER PRIMARY HIP REPLACED ABOUT 15 YEARS AGO. PATIENT HAD A LARGE AMOUNT OF HETEROTROPIC BONE AROUND CUP AND SURGEON CHANGED TO A 32 MM + 4 N LINER AND 32 CERAMIC +6 HEAD. ADVISED HIM THERE IS NOT A SLEEVE IN HEAD AND IS A PRIMARY THR HEAD. DOI: UNKNOWN; DOR: (B)(6) 2019; LEFT HIP.

  Patient problems: No Code Available

  MAUDE report 9482371 ↗
• InjuryNov 9, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF ALLEGES LOOSENING OF CUP, FRACTURE (COMPONENT), DISLOCATION WITH OPEN REDUCTION, AND LOOSENING OF STEM. IT WAS ALSO INDICATED IN THE REVISION STICKER SHEETS THAT THE LINER, HEAD AND STEM WERE REMOVED ON (B)(6) 2009. DOI: (B)(6) 2007 (STEM). DOI: (B)(6) 2009 (LINER, HEAD). DOR: (B)(6) 2009 (RIGHT HIP).

  Patient problems: Joint Dislocation

  MAUDE report 8055026 ↗