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BIOLOX DELTA 1365-44-710Recalls & reported problems

Depuy Orthopaedics, Inc. · BIOLOX DELTA TS CERAMIC FEMORAL HEAD 12/14 TAPER REVISION Diameter 44mm +1.5 · Class 3 · Implant

All models of BIOLOX DELTA (40)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
3
Deaths reported
0
Injuries reported
3
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295033813), received between Dec 19, 2018 and Apr 8, 2019 — classified as 3 injuries.

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

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

Device problems

  • Adverse Event Without Identified Device or Use Problem1
  • Device Dislodged or Dislocated1
  • Naturally Worn1

Patient problems

  • Joint Dislocation2
  • Tissue Damage2
  • Unspecified Infection2
  • No Code Available1
  • Test Result1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • InjuryApr 8, 2019Naturally Worn; Naturally Worn

    PPF ALLEGE METAL WEAR AND METALLOSIS. DOI: (B)(6) 2007 CUP AND STEM. DOI: (B)(6) 2011 HEAD AND LINER. DOR: (B)(6) 2011 (RIGHT HIP).

    Patient problems: Tissue Damage; Unspecified Infection

    MAUDE report 8490803 ↗
  • InjuryMar 13, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

    PPF AND MEDICAL RECORDS RECEIVED. PPF ALLEGES PSEUDOTUMOR, CONSTRAINED LINER, ABDUCTOR MUSCLE REPAIR, DISLOCATION WITH OPEN REDUCTION AND ELEVATED METAL IONS AFTER FIRST REVISION. AFTER REVIEW OF MEDICAL RECORDS, THERE WAS NO OPERATIVE NOTE PROVIDE FOR THE SECOND REVISION. THE POLYETHYLENE LINER, CERAMIC HEAD, AND THE STEM WERE REPORTED TO THE IMPACTED PRODUCT DUE TO THE PPF ALLEGATION. DOI: (B)(6) 2012 - DOR: (B)(6) 2013 (RIGHT HIP) SECOND REVISION.

    Patient problems: Joint Dislocation; No Code Available; Test Result; Tissue Damage

    MAUDE report 8416496 ↗
  • InjuryDec 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    PPF ALLEGES DISLOCATION AND INFECTION AFTER FIRST REVISION. DOI: (B)(6) 2015 - DOR: NONE REPORTED (LEFT HIP). SEE (B)(4) FOR THE FIRST REVISION.

    Patient problems: Joint Dislocation; Unspecified Infection

    MAUDE report 8181230 ↗

Other Prosthesis, hip, semi-constrained (metal uncemented acetabular component) devices

All Prosthesis, hip, semi-constrained (metal uncemented acetabular component) devices →

Sources and updates

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