BIOLOX delta 76539160Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 03596010566928), received between Apr 28, 2017 and Mar 9, 2021 — classified as 10 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 reports).

1 other recall cover devices cleared under the same FDA submission (K083762, K211176); they may or may not involve this specific model.

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 16, 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.

• InjuryMar 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO A PROXIMAL FEMUR PERIPROSTHETIC FRACTURE. THE ENTIRE FEMORAL COMPONENT WAS REVISED. THE OUTCOME IS RESOLVED.

  Patient problems: Bone Fracture(s)

  MAUDE report 11449628 ↗
• InjuryJun 18, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT AFTER THA ON THE RIGHT THE PATIENT IS NOTED WITH HIP DISLOCATION AT ARRIVAL TO RECOVERY ROOM. NO FURTHER DETAILS PROVIDED. SUBJECT WAS DISCHARGED HOME WITH 2 CRUTCHES.

  Patient problems: Injury

  MAUDE report 10170148 ↗
• InjuryNov 26, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WAS PARTICIPATING ON THE "(B)(6) STUDY" AND UNDERWENT A REVISION SURGERY OF THE HEAD, SHELL AND LINER DUE TO UNKNOWN REASONS.

  Patient problems: Injury

  MAUDE report 9375579 ↗
• InjuryOct 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS PARTICIPATING ON THE "MULTI-CENTER, RANDOMIZED CONTROLLED STUDY OF EFFICACY AND SAFETY OF THE OXINIUM DH TOTAL HIP REPLACEMENT SYSTEM IN SUBJECTS WITH NON-INFLAMMATORY ARTHRITIS STUDY" AND UNDERWENT A REVISION SURGERY OF THE HEAD, SHELL AND LINER DUE TO UNKNOWN REASONS.

  Patient problems: Injury

  MAUDE report 9191729 ↗
• MalfunctionJul 14, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT UPON OPENING THE PACKAGING OF THE BIOLOX DURING SURGERY IT WAS FOUND THAT THE INNER PACKAGING WAS COMPROMISED. NO BACKUP WAS AVAILABLE SO THE SAME IMPLANT WAS STERILIZED DURING 20 MINUTES AND THE USED. A DELAY OF 31 TO 60 MINUTES REPORTED. NO PATIENT INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8787548 ↗
• InjuryJan 22, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT PRESENTS ILIOPSOAS TENDINITIS ON OPERATIVE HIP. THIS WAS FOUND AFTER SURGERY. DEVICE BACK UP NOT APPLICABLE AND DELAY DURING PROCEDURE IS UNKNOWN.

  Patient problems: Injury

  MAUDE report 8266446 ↗
• InjuryAug 27, 2018Device Slipped

  IT WAS REPORTED A SUBLUXATION OF HEAD OF FEMORAL COMPONENT OF HIP IMPLANT DUE TO LIGAMENTOUS LAXITY. EVENT WAS TREATED WITH REST. NO DELAY TO THE PROCEDURE. SUBJECT ID: (B)(6); DATE OF SURGERY: (B)(6) 2017; AGE: (B)(6); SEX: FEMALE.

  Patient problems: No Code Available

  MAUDE report 7820420 ↗
• InjuryMar 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A CORTISONE INJECTION WAS REQUIRED DUE TO RIGHT LATERAL HIP PAIN.

  Patient problems: Pain

  MAUDE report 7353110 ↗
• InjuryFeb 17, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A SURGICAL INTERVENTION WAS PERFORMED DUE TO THIGH PAIN AND THICKENING OF LATERAL FEMORAL CORTEX. THE LINER, THE STEM AND THE HEAD WERE REMOVED.

  Patient problems: Pain

  MAUDE report 7279477 ↗
• InjuryFeb 13, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT PATIENT PRESENTED A DISLOCATION OF LEFT THR WHEN TRANSFERRING FROM BED TO CHAIR DUE TO LOOSE FEMORAL COMPONENT. REVISION SURGERY WAS REQUIRED.

  Patient problems: Joint Dislocation

  MAUDE report 7265858 ↗
• InjuryApr 28, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT A RIGHT HIP STEROID INJECTION DUE TO PAIN.

  Patient problems: Pain

  MAUDE report 6531894 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K083762, K211176. One submission often covers many models, so check the product and lot details in each record.

• Z-0326-2025 · Oct 15, 2024 · Open, Classified
  Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF 71324046, sterile, femoral head bipolar component of the Tandem Bipolar Hip System.