ENDURO NR881MRecalls & reported problems
Aesculap AG · ENDURO MENISCAL COMPONENT F2 12MM · Class 2 · Implant
All models of ENDURO (7)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04046964010293), received between Sep 15, 2021 and Nov 11, 2021 — 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
Device problems
- Fracture2
- Material Fragmentation1
Patient problems
- Failure of Implant3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryNov 11, 2021Material Fragmentation; Material Fragmentation
CORRECTION: ADDED INVOLVED COMPONENT - NR860K CHANGED FROM LEADING MATERIAL TO INVOLVED COMPONENT AFTER INVESTIGATION. ASSOCIATED MEDWATCH-REPORTS: 9610612-2021-00638 (400527610 + NR860K). 9610612-2021-00717 (400532704 + NR881M). INVOLVED COMPONENTS: NB018K - ENDURO FEMORAL COMPONENT CEMENTED F2R - LOT: 52079897. NR860K - ENDURO LOCKING NUT F/ROTATION AXIS - LOT: 52291905.
Patient problems: Failure of Implant
MAUDE report 12796514 ↗InjurySep 16, 2021Fracture; Fracture
IT WAS REPORTED TO AESCULAP AG THAT AN ENDURO MENISCAL COMPONENT F2 12MM (PART # NR881M) WAS USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THERE WAS A FRACTURE OF ROTATION AXIS. THE PATIENT UNDERWENT A REVISION SURGERY. THE COMPLAINT DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. A REVISION SURGERY 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 12482142 ↗InjurySep 15, 2021Fracture; Fracture
ADDITIONAL INVOLVED MATERIALS: NR293K - FEMUR EXTENS. STEM 6° D18X77MM CEMENTED. NB018K - ENDURO FEMORAL COMPONENT CEMENTED F2R. NR860K - ENDURO LOCKING NUT F/ROTATION AXIS. NR377K - ENDURO FEMUR SPACER POST/DIST F2 4X8MM. NB011K - ENDURO TIBIAL COMP. OFFSET CEMENTED T1. NR195K - TIBIA OFFSET STEM D15X92MM CEMENTED. NR400K - NUT F/FEMUR EXTENS. STEM ALL SIZES NEUTR. AE-QAS-COMPET-IMP - COLLECT. NO. QAS IMPLANTS FROM COMPETITORS.
Patient problems: Failure of Implant
MAUDE report 12477980 ↗
Other PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER devices
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- "UNITED" USTAR II Hip System 1115-1413United Orthopedic Corp. · Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer3 recalls3 reports
- "UNITED" USTAR II Hip System 1115-1217United Orthopedic Corp. · Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer3 recalls0 reports
- "UNITED" USTAR II Hip System 1115-1417United Orthopedic Corp. · Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer3 recalls0 reports
- "UNITED" USTAR II Hip System 1115-1213United Orthopedic Corp. · Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer3 recalls0 reports
- Endo-Model Modular Knee Prosthesis System 15-3816/11WALDEMAR LINK GmbH & Co. KG · Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer2 recalls6 reports
- Endo-Model Modular Knee Prosthesis System 15-3816/12WALDEMAR LINK GmbH & Co. KG · Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer2 recalls6 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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