BIOLOX delta 71346004Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010656711), received between Jan 31, 2020 and Sep 12, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Unintended Movement” (1 report).

1 other recall cover devices cleared under the same FDA submission (K100412, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY OF HIS RIGHT THA SYSTEM (UNKNOWN PRODUCT) ON (B)(6) 2020 DUE TO PERIPROSTHETIC JOINT INFECTION, AND RIGHT TOTAL HIP ARTHROPLASTY WITH MULTIPLE DISLOCATIONS. DURING THE REVISION SURGERY, THE WHOLE PRIMARY THA SYSTEM WAS EXPLANTED AND REPLACED WITH A REDAPT MODULAR SHELL WITH A REDAPT STEM. AS REPORTED, ON (B)(6) 2020, THE PATIENT SUFFERED FROM INSTABILITY FOLLOWING RIGHT REVISION THA AND PERIPROSTHETIC JOINT INFECTION AND WAS REVISED AGAIN. DURING THIS SECOND REVISION SURGERY, THE FEMORAL HEAD, AND THE ACETABULAR LINER WERE EXPLANTED. THERE IS NO FURTHER INFORMATION AT THIS TIME. THE CURRENT STATE OF HEALTH OF THE PATIENT IS UNKNOWN.

  Patient problems: Joint Laxity; Medical device site infection

  MAUDE report 20203020 ↗
• InjuryJan 31, 2020Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE PATIENT UNDERWENT TWO CLOSED REDUCTIONS, FOLLOWED BY REVISION SURGERY OF LINER, HEAD AND SLEEVE DUE TO RECURRENT DISLOCATIONS. THE FIRST CLOSED REDUCTION WAS PERFORMED ON (B)(6) 2018 AND THE SECOND ONE ON (B)(6) 2018. FINALLY, THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2019.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 9653047 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K100412, 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.