AS ENDURO NB014ZRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04046963177485), received between May 6, 2021 and Nov 19, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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.

• InjuryNov 19, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED TO AESCULAP INC. THAT AN AS ENDURO FEMORAL COMPONENT CEMENTED F1L (PART # NB014Z) WAS IMPLANTED IN A PATIENT ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT THE PATIENT CURRENTLY PRESENTS WITH TIBIAL BASE PLATE LOOSENING AND CONTINUED LEFT PAINFUL KNEE ARTHROPLASTY. REPORTEDLY A REVISION PROCEDURE WAS SCHEDULED FOR (B)(6) 2024. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4). ASSOCIATED MEDWATCH REPORTS: 2916714-2024-00186 (AIC REFERENCE NO. (B)(4)), 2916714-2024-00187 (AIC REFERENCE NO. (B)(4)), 2916714-2024-00188 (AIC REFERENCE NO. (B)(4)), 2916714-2024-00189 (AIC REFERENCE NO. (B)(4)), 2916714-2024-00190 (AIC REFERENCE NO. (B)(4)), 2916714-2024-00191 (AIC REFERENCE NO. (B)(4)).

  Patient problems: Failure of Implant; Implant Pain

  MAUDE report 20722533 ↗
• InjuryMay 6, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED TO AESCULAP AG THAT A AS ENDURO FEMORAL COMPONENT CEMENTED F1L (PART # NB014Z) WAS IMPLANTED DURING A PRIMARY SURGERY PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, THE ADOPTION OF ABRASION COATING LED TO LOOSENING OF THE PROSTHESIS. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2021. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE XC (B)(4). INVOLVED COMPONENTS: NR406Z - AS FEMUR EXTENS.STEM 5° D16X117 CEM.LESS - 52491231, NR400Z - AS NUT F/FEMUR EXTENS.STEM ALL SZ.NEUTR. - 52532547, NR887M - ENDURO MENISCAL COMPONENT F2 24MM - BATCH UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 11787774 ↗