BIOLOX DELTA 1365-44-720Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295033820), received between Nov 29, 2018 and Apr 8, 2020 — classified as 6 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryApr 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PFS ALLEGES THAT THE PATIENT CONTINUES TO EXPERIENCE PAIN AND DECREASED MOBILITY. DOI: (B)(6) 2013; DOR: NO REVISION REPORTED (RIGHT HIP).

  Patient problems: Limited Mobility Of The Implanted Joint; No Code Available; Pain

  MAUDE report 9935823 ↗
• InjuryNov 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES INFECTION AND ELEVATED METAL IONS. DOI: (B)(6) 2012; DOR: (B)(6) 2012 (LEFT HIP). PPF NOTED THAT NOTHING WAS REMOVED ON THIS DATE BUT A CERAMIC IMPLANT WAS PUT IN TO FILL THE SPACE CREATED BY THE REMOVAL OF THE METAL IMPLANT REMOVED ON (B)(6) 2012. THIS PC IS FOR THE SECOND REVISION OF THE LEFT HIP. SEE (B)(4) FOR THE FIRST REVISION.

  Patient problems: Metal Related Pathology; No Code Available; Test Result; Unspecified Infection

  MAUDE report 9337519 ↗
• InjurySep 10, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGED DISLOCATION (CLOSED AND OPEN REDUCTION) AFTER FIRST REVISION. DOI: (B)(6) 2013, DOR: (B)(6) 2015, RIGHT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8983087 ↗
• InjuryApr 16, 2019No Apparent Adverse Event; No Apparent Adverse Event

  PPF ALLEGES ELEVATED METAL IONS AFTER THE FIRST REVISION. (RIGHT HIP).

  Patient problems: Test Result

  MAUDE report 8519936 ↗
• InjuryApr 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF ALLEGES PSEUDOTUMOR. ALTHOUGH MEDICAL RECORDS WERE NOT PROVIDED, A DATA GIVEN STATING THAT PATIENT HAD A HISTORY OF RIGHT TOTAL HIP ARTHROPLASTY FAILURE WITH, MULTIPLE REVISION INCLUDING HISTORY OF ABDUCTOR DEFICIENCY DUE TO METALLOSIS. IT WAS ALSO STATED THAT FEMORAL IMPLANT HAS SUBSIDED MORE THAN AN INCH AND IS GROSSLY LOOSE. DOI: (B)(6) 2004 - DOR: (B)(6) 2012 (RIGHT HIP).

  Patient problems: Tissue Damage

  MAUDE report 8508354 ↗
• InjuryNov 29, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES DISLOCATION.

  Patient problems: No Information

  MAUDE report 8114934 ↗