AS ENDURO NR870ZRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04046963937621), received between Aug 10, 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 MENISCAL COMPONENT F1 10MM. (PART # NR870Z) 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 20722498 ↗
• InjuryAug 10, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  CORRECTION/ADDITIONAL INFORMATION CHANGE FROM LEADING MATERIAL TO INVOLVED COMPONENT: (B)(6) - AS ENDURO MENISCAL COMPONENT F1 10MM. NEW LEADING MATERIAL: 9610612-2021-00748 ((B)(6) - AS FEMUR EXTENS.STEM 5° D18X117 CEM.LESS). IMPLANTATION: (B)(6) 2011. 1. REVISION: (B)(6) 2013. 2. REVISION: (B)(6) 2021. IMPLANTATION OF THE ENDURO KTEP ON THE LEFT ON (B)(6) 2013 AS PART OF A TWO-STAGE SEPTIC PROSTHESIS CHANGE. THERE WERE NO INTERIM FOLLOW-UP VISITS. BEFORE THE PERACUTE DETERIORATION, THE KNEE HAD NOT BEEN PAIN-FREE FOR SOME TIME. THE CURRENT DETERIORATION WAS ALSO PRECEDED BY A FALL. RADIOLOGICAL DISCONNECTION OF THE ANCHORING NUT WITH UNCOUPLING OF THE FEMORAL COMPONENT FROM THE STEM EXTENSION AND SUBSEQUENT INSTABILITY. THE RESULT WAS INSTABILITY OF THE KNEE JOINT, WHICH LED TO REVISION SURGERY. A REVISION SURGERY WAS NECESSARY. ADDED INVOLVED COMPONENTS: INVOLVED COMPONENTS. (B)(6) - AS TIBIA OFFSET STEM D17X92 CEMENTLESS - LOT 51889470. (B)(6) - AS ENDURO TIBIAL COMP.OFFSET CEMENTED T1 - LOT 51959113. (B)(6) - AS ENDURO FEMORAL COMPONENT CEMENTED F1L - LOT 51965668. (B)(6) - AS ENDURO MENISCAL COMPONENT F1 10MM - LOT 51910601. (B)(6) - AS NUT F/FEMUR EXTENS.STEM ALL SZ.NEUTR. -

  Patient problems: Failure of Implant

  MAUDE report 12303254 ↗