BIOLOX DELTA 1365-44-730Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295033837), received between Nov 2, 2018 and Aug 21, 2019 — classified as 6 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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.

• InjuryAug 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF REPORTED THAT THE HEAD WAS REVISED AFTER 1ST REVISION ON (B)(6) 2014 WHEN CULTURE CAME BACK POSITIVE FOR INFECTION. DOI: (B)(6) 2014. DOR: (B)(6) 2014. LEFT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8917035 ↗
• InjuryJul 11, 2019Device Dislodged or Dislocated; Naturally Worn; Noise, Audible; Device Dislodged or Dislocated; Naturally Worn; Noise, Audible

  OFFICE NOTES (B)(6) 2007 INDICATE THE PATIENT IS EXPERIENCING PAIN, POPPING, AND LOCKING FEELINGS WITHIN THE RIGHT HIP. RADIOLOGY REPORT (B)(6) 2008 INDICATES THE PATIENT HAS A RIGHT TOTAL HIP WITH EVIDENCE OF BONE FRACTURE. FINDINGS FROM THE RADIOLOGY IMAGES INCLUDE THAT THE PATIENT IS STATUS POST TOTAL RIGHT HIP ARTHROPLASTY WITH FIXATION PLATE AND SCREWS TRANSFIXING AN ACETABULAR FRACTURE.

  Patient problems: Ambulation or Postural Difficulties; Embolism/Embolus; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Inflammation; Joint Dislocation; Joint Laxity; Pain; Pulmonary Embolism; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 8780666 ↗
• InjuryApr 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF ALLEGE PSEUDOTUMOR AND ELEVATED METAL IONS. STEM WAS ALREADY REPORTED IN FIRST PC. (RIGHT HIP).

  Patient problems: Test Result; Tissue Damage

  MAUDE report 8556866 ↗
• InjuryApr 17, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  LITIGATION ALLEGES DISLOCATION AFTER 1ST REVISION. DOI: (B)(6) 2014, DOR: NONE REPORTED, (LEFT HIP).

  Patient problems: Joint Dislocation

  MAUDE report 8522325 ↗
• InjuryNov 13, 2018Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available; Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES CONSTRAINED LINER AND DISLOCATION WITH CLOSED REDUCTION.

  Patient problems: Joint Dislocation

  MAUDE report 8065160 ↗
• InjuryNov 2, 2018Fracture; Fracture

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES STROKE/HEART ATTACK, FRACTURE AND ELEVATED METAL IONS.

  Patient problems: Infarction, Cerebral

  MAUDE report 8032569 ↗