BIOLOX DELTA 1365-28-230Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295033264), received between Aug 3, 2017 and Oct 23, 2025 — classified as 8 injuries, 1 malfunction.

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryOct 23, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO DISLOCATION; A NON-DEPUYSYNTHES DEVICE WAS USED AS A REPLACEMENT. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Joint Dislocation

  MAUDE report 23372667 ↗
• MalfunctionMay 5, 2022Fracture; Fracture

  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: Insufficient Information

  MAUDE report 14287833 ↗
• InjuryApr 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN; DOR: (B)(6) 2022; AFFECTED SIDE: UNKNOWN.

  Patient problems: Pain

  MAUDE report 13977063 ↗
• InjuryJan 8, 2021Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  A. WAS THERE SURGICAL DELAY DURING REVISION? IF YES, PLEASE INDICATE THE DURATION. ANSWER: NO. B. WAS THE DISLOCATION CONFIRMED? ANSWER: YES. C. CAN YOU PLEASE CONFIRM WHAT YOU MEANT BY "THE SURGEON SUSPECT MAYBE BEFORE IMPLANT THE HEAD WERE CRACKING." WAS THE HEAD ALREADY CRACKED BEFORE IT WAS IMPLANTED? ANSWER: YES, BUT MAYBE LITTLE CRACKING WOULD NOT BE OBSERVED BY NAKED EYE.

  Patient problems: Joint Dislocation; Pain

  MAUDE report 11140086 ↗
• InjuryDec 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPDATE AD 21 APR 2022: PFS, PPF, AND MEDICAL RECORD RECEIVED. THIS WAS REVIEWED BY CLINICIAN AND HAVE THE FINDING THAT ON 13 OCT 2017, HEAD/LINER/CUP RIGHT HIP (POLY ON CERAMIC) THE PATIENT HAD A REVISION RIGHT TOTAL HIP ARTHROPLASTY TO ADDRESS FAILED RIGHT TOTAL HIP ARTHROPLASTY. THE INDICATIONS FOR SURGERY INCLUDED, SUDDEN ONSET OF PAIN. RADIOGRAPHS SHOWED EVIDENCE OF DISPLACEMENT OF THE ACETABULAR COMPONENT WITH EVIDENCE OF AN ACETABULAR FRACTURE. DURING THE PROCEDURE, THE SURGEON OBSERVED, THE CUP AND TWO SCREWS WERE REMOVED, THE CUP WAS NOTED TO BE GROSSLY LOOSE. ZIMMER PRODUCTS WERE USED ALONG WITH DEPUY FEMORAL HEAD. (10/13/2017 STICKER PAGE 11 OF 11) CT SCAN DATED (B)(6) 2017 FINDINGS STATED THAT THERE IS SUPERIOR, LATERAL AND POSTERIOR DISPLACEMENT PLUS ABNORMAL VERTICAL ANGULATION OF THE ACETABULAR CUP IN RELATION TO THE NATIVE ACETABULUM IN KEEPING WITH CUP DISLOCATION , PSEUDOARTHROSIS,HEMARTHROSIS, HEMATOMA, EDEMA, AND FLUID. ADDED BIPOLAR HEAD, CUP AND SCREWS TO THIS COMPLAINT. UPDATED PRODUCT DETAILS OF HEAD AND LINER AND ADDED PATIENT'S INITIALS, AGE, DOB, GENDER, AND MEDICAL HISTORY. CORRECTED DOI. DOI: (B)(6) 2017 - DOR: OCT 13, 2017 (RIGHT HIP).

  Patient problems: Foreign Body Reaction; Hematoma; Hemorrhage/Blood Loss/Bleeding; Inflammation; Pain

  MAUDE report 10991613 ↗
• InjuryJul 16, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT HAD REVISION LEFT HIP HEAD AND LINER EXCHANGE. S-ROM STEM WITH STRYKER CONSTRAINED CUP. PATIENT WAS DISLOCATED AND ONLY HEAD AND LINER WERE EXCHANGED. ORIGINAL IMPLANT DATE UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2020; AFFECTED SIDE: LEFT HIP

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 10282972 ↗
• InjuryJun 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD VERY HIGH HIP CENTER ON PRIMARY HIP PERFORMED IN (B)(6) 2019 AND AT THAT TIME PATIENT WAS LEFT SHORT. TODAY, A LONGER STEM WAS PLACED TO GET THE PATIENT BACK CLOSER TO EQUAL LEG LENGTHS. DOI: (B)(6) 2019. DOR: (B)(6) 2020. RIGHT HIP.

  Patient problems: No Code Available

  MAUDE report 10111344 ↗
• InjuryNov 14, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  LITIGATION ALLEGES LOOSENING OF CUP, LOOSENING OF STEM, FRACTURE COMPONENT AND DISLOCATION WITH OPEN REDUCTION AFTER FIRST REVISION.

  Patient problems: Inadequate Osseointegration; Joint Dislocation

  MAUDE report 8071410 ↗
• InjuryAug 3, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 6764317 ↗