BIOLOX delta 76539166Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 03596010566966), received between Jan 30, 2018 and Apr 13, 2022 — classified as 1 death, 8 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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. How this data works · Data updated Oct 13, 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.

• DeathApr 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A BILATERAL THR SURGERY PERFORMED (ONLY ONE IS FROM SMITH AND NEPHEW) ON (B)(6) 2010, THE CLINICAL SUBJECT PASSED AWAY ON (B)(6) 2020. THE CAUSE OF DEATH IS UNKNOWN. FURTHER INFORMATION IS NOT AVAILABLE AT THE TIME.

  Patient problems: Insufficient Information

  MAUDE report 14103405 ↗
• InjuryAug 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER THR REVISION SURGERY HAD BEEN PERFORMED ON (B)(6) 2021, THE PATIENT EXPERIENCED AN INFECTION. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2021, TO WASH OUT AND REPLACE THE BIOLOX DELTA HEAD 36 MM 12/14 M / +4 AND A COMPETITOR BRAND LINER. CURRENT STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 12329300 ↗
• InjuryJan 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, A SECOND REVISION SURGERY WAS PERFORMED DUE TO PATIENT DISLOCATING. THE R3 36MM ID DLT CER LNR MM64 WITH METAL SLEEVE AND BIOLOX DELTA HEAD 36 MM 12/14 M WERE REMOVED. THE PROCEDURE WAS COMPLETED WITH SN BACK UP DEVICES. IT IS UNKNOWN IT THERE WAS A SURGICAL DELAY. NO OTHER COMPLICATIONS WERE REPORTED. (THE PREVIOUS REPORTED REVISION SURGERY WAS DUE TO HEAD IMPLANT BREAKAGE). ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Joint Dislocation

  MAUDE report 11113619 ↗
• InjuryFeb 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD LOW HAEMOGLOBIN AND REQUIRED 3 UNITS OF BLOOD TRANSFUSION.

  Patient problems: Injury

  MAUDE report 9670763 ↗
• InjuryJan 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED AND AN INFECTION WAS CONFIRMED. HEAD WAS REMOVED. AN ANTIBIOTIC SPACER WAS USED.

  Patient problems: Unspecified Infection

  MAUDE report 9636216 ↗
• InjuryDec 10, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED DUE TO LEG PAIN. THIS WAS TREATED VIA NERVE ROOT BLOCK (INJECTION).

  Patient problems: Pain

  MAUDE report 9446661 ↗
• InjuryOct 30, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED TO EXCHANGE THE HEAD AND THE LINER, DUE TO SQUEAKING NOISES AND EDGE LOADING.

  Patient problems: Injury

  MAUDE report 9255905 ↗
• InjuryDec 14, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A DISLOCATION OCCURRED. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Injury

  MAUDE report 8167174 ↗
• InjuryJan 30, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT PATIENT HAD A REVISION SURGERY DUE TO A FALL AT A NURSING FACILITY TWO WEEKS POST OPERATION AND RESULTED IN A PERI PROSTHETIC FRACTURE THAT REQUIRED THE EXPLANTATION OF THE FEMORAL HEAD IMPLANT.

  Patient problems: Injury

  MAUDE report 7227913 ↗

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.