ENDURO NR880MRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04046964010286), received between Jun 4, 2021 and Mar 18, 2022 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 18, 2022Fracture; Fracture

  IT WAS REPORTED TO AESCULAP AG THAT AN ENDURO MENISCAL COMPONENT F2 10MM (PART # NR880M) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2019 ACCORDING TO THE COMPLAINANT, TWO (2) YEARS AFTER THE PROCEDURE, THE AXIS OF THE DEVICE FRACTURED. THE PATIENT UNDERWENT A REVISION PROCEDURE ON AN UNKNOWN DATE. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. A REVISION SURGERY WAS NECESSARY. ADDITIONAL INFORMATION WAS NOT PROVIDED. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4). INVOLVED COMPONENTS NB015K - ENDURO FEMORAL COMPONENT CEMENTED F2L - LOT 52542132

  Patient problems: Failure of Implant

  MAUDE report 13809240 ↗
• InjuryFeb 25, 2022Fracture; Fracture

  IT WAS REPORTED TO AESCULAP AAG THAT AN ENDURO MENISCAL COMPONENT F2 10MM (PART # NR880M) WAS IMPLANTED DURING A PRIMARY PROCEDURE PERFORMED ON (B)(6), 2016. ACCORDING TO THE COMPLAINANT, FOLLOWING A PATIENT TRAUMA, THE DEVICE EXPERIENCED AN AXLE FRACTURE. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6), 2022. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. A REVISION SURGERY WAS NECESSARY. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 13599497 ↗
• InjuryJun 4, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  CORRECTION/ADDITIONAL INFORMATION: NR880M - ENDURO MENISCAL COMPONENT F2 10MM - LOT 52223023 WAS CHANGED FROM LEADING MATERIAL TO INVOLVED COMPONENT. ASSOCIATED MEDWATCH REPORTS: 9610612-2021-00416, 9610612-2021-00440.

  Patient problems: Failure of Implant

  MAUDE report 11938276 ↗