Biolox® delta 00-8775-032-02 (UDI 00889024276741)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889024276741), received between Oct 23, 2024 and Oct 23, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

3 other recalls cover devices cleared under the same FDA submission (K071535); 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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryOct 23, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A PATIENT HAD A LEFT TOTAL HIP ARTHROPLASTY. THE PATIENT DID WELL UNTIL SUSTAINING AN INJURY WHILE AT WORK. IT WAS REPORTED THAT HE WAS STANDING ON BOXES OR SOME PLATFORM THAT SPREAD APART, AND HE DID THE SPLITS AND DISLOCATED HIS LEFT HIP WHICH PRIOR HAS NOT HAD ANY DISLOCATIONS. SINCE THAT TIME, HE HAS HAD 12 MORE DISLOCATIONS. THE PATIENT WAS REVISED APPROXIMATELY 11 YEARS POST-IMPLANTATION, DURING WHICH ABUNDANT SCAR TISSUE WAS REMOVED. THE SHELL AND STEM WERE WELL-SEATED AND REMAINED INTACT. THE HEAD, LINER, AND NECK WERE REPLACED WITHOUT COMPLICATION. DUE DILIGENCE HAS BEEN COMPLETED FOR THIS COMPLAINT; TO DATE ALL AVAILABLE ADDITIONAL INFORMATION HAS BEEN RECEIVED.

  Patient problems: Joint Dislocation; Scar Tissue

  MAUDE report 20517387 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K071535. One submission often covers many models, so check the product and lot details in each record.

• Z-0336-2020 · Oct 10, 2019 · Terminated
  Ceramic Femoral Heads, various sizes, Item Nos. 00877504001 00877504002 00877504003 00877504004
• Z-1134-2015 · Dec 17, 2014 · Terminated
  Biolox Delta Femoral Head - The BIOLOX delta Ceramic Femoral Head is used in conjunction with compatible acetabular and femoral stem components in total hip arthroplasty. A variety
• Z-0211-2013 · Sep 4, 2012 · Terminated
  Biolox delta Ceramic Femoral Head Rx only, sterile