Biolox® forte NJ108Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04038653304356), received between Dec 1, 2020 and Jun 9, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Fracture” (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 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.

• InjuryJun 9, 2021Fracture; Fracture

  CORRECTION: NJ108- BIOLOX PROSTHESIS HEAD 8/10 32MM L- AAG REFERENCE (B)(4) IS NO LONGER REPORTABLE AS IT CHANGED FROM LEADING MATERIAL TO INVOLVED COMPONENT. ASSOCIATED MEDWATCH-REPORTS: 9610612-2022-00087 ((B)(4) - NH102) AND 9610612-2021-00426 ((B)(4) - NJ108). INVOLVED COMPONENTS: NH048T - PLASMACUP SC SIZE 48MM - 51407851. NJ011T - BICONTACT N PLASMAPORE 8/10 SIZE 11MM - 51344702A. NJ108 - BIOLOX PROSTHESIS HEAD 8/10 32MM L - 51422587.

  Patient problems: Failure of Implant; Pain

  MAUDE report 11970824 ↗
• InjuryDec 1, 2020Fracture; Fracture

  IT WAS REPORTED TO AESCULAP AG THAT A BIOLOX PROSTHESIS HEAD (PART # NJ108) WAS USED DURING A TOTAL HIP ARTHROPLASTY PROCEDURE OF THE RIGHT LEG. THE FIRST IMPLANTATION SURGERY WAS PERFORMED ON (B)(6) 2008 AT (B)(6) HOSPITAL. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2020, THE CERAMIC IMPLANT WAS CONFIRMED AS BEING FRACTURED, WHICH RESULTED IN A REVISION SURGERY BEING SCHEDULED, AND THEN PERFORMED ON (B)(6) 2020. BOTH THE CERAMIC INSERT AND THE FEMORAL HEAD WERE FOUND TO BE BROKEN. THE PATIENT HAD UNDERGONE A COMPUTERIZED TOMOGRAPHY (CT) SCAN TO CONFIRM THE BREAK PRIOR TO THE REVISION SURGERY. ADDITIONALLY, THE CERAMIC IMPLANTS WERE NOTED AS HAVING BEEN BROKEN APPROXIMATELY TWO (2) WEEKS BEFORE THE REVISION SURGERY. THE DEVICE IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. ALTHOUGH THE PATIENT EXPERIENCED HIP PAIN AS A RESULT OF THE BREAK, THE PATIENT WAS ABLE TO WALK "AS USUAL." NO FURTHER PATIENT INFORMATION HAS BEEN MADE AVAILABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT HAS NOT BEEN MADE AVAILABLE. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4). INVOLVED COMPONENTS: NH102-SC/MSC CERAMICS INSERT 32MM 48/50 SYM - LOT # 51450162.

  Patient problems: Failure of Implant

  MAUDE report 10924885 ↗