ENDURORecalls & reported problems across all models
Aesculap AG · 7 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls
- 1
We found 7 models of ENDURO by Aesculap AG in the FDA's device registry (GUDID). Together they are named in 11 adverse event reports in the FDA's MAUDE database, received between Mar 16, 2021 and Mar 18, 2022 — classified as 10 injuries, 1 malfunction.
The most frequently reported specific device problem is “Fracture” (6 reports).
1 FDA recall record name at least one of these models by its device identifier.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
ENDURO recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Nov 12, 2019Completed
Nonfunctional key due to the potential for damage to the key pins cause by force of use during assembly of the tibia locking ring.
Z-1391-2022 · Root cause: Device Design · Recall details · FDA record ↗
Most reported ENDURO problems
Device problems
- Fracture6
- Loosening of Implant Not Related to Bone-Ingrowth2
- Lack of Maintenance Documentation or Guidelines1
- Material Fragmentation1
- Mechanical Problem1
Patient problems
- Failure of Implant9
- No Clinical Signs, Symptoms or Conditions2
ENDURO models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ENDURO NP462RORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 recall0 reports
- ENDURO NR880MPROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER3 reports
- ENDURO NR881MPROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER3 reports
- ENDURO NB019KPROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER2 reports
- ENDURO NP451RTEMPLATE1 report
- ENDURO NR882MPROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- ENDURO NR891MPROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER1 report
Recent ENDURO adverse event reports
The 11 most recent reports across all models, 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 ↗InjuryMar 3, 2022Fracture; Fracture
IT WAS REPORTED TO AESCULAP AG THAT AN ENDURO MENISCAL COMPONENT F2 14MM (PART # NR882M) WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, POST OPERATIVE FRACTURE OF IMPLANT DUE TO BROKEN COUPLING MECHANISM. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022. INTRAOPERATIVELY, IT WAS CONFIRMED THAT THE PEG CONNECTING THE TIBIA AND FEMUR WAS BROKEN. IT COULD BE REPLACED WITHOUT ANY PROBLEMS. A REVISION SURGERY WAS NECESSARY. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4). INVOLVED COMPONENTS: NR400K - NUT F/FEMUR EXTENS.STEM ALL SIZES NEUTR. - LOT 52431584; NX044 - PATELLA 3-PEGS P4 - LOT 52120232; NB018K - ENDURO FEMORAL COMPONENT CEMENTED F2R - LOT 52438796; NB012K - ENDURO TIBIAL COMP.OFFSET CEMENTED T2 - LOT 52431525; NR175K - TIBIA OFFSET STEM D15X92MM CEMENTLESS - LOT 52324310; NR409K - FEMUR EXTENS.STEM 5° D19X117MM CEM.LESS - LOT 51946677.
Patient problems: Failure of Implant
MAUDE report 13663511 ↗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 ↗InjuryFeb 18, 2022Fracture; Fracture
IT WAS REPORTED TO AESCULAP AG THAT AN ENDURO FEMORAL COMPONENT CEMENTED F3R (PART # NB019K) WAS IMPLANTED DURING A PRIMARY SURGERY PERFORMED ON (B)(6) 2015. ACCORDING TO THE COMPLAINANT, THERE WAS A MATERIAL FRACTURE AT THE JUNCTION OF FEMORAL SHIELD AND STEM. IMPLANTATION WAS DONE DURING TRACHEOESOPHAGEAL PUNCTURE (TEP) EXCHANGE IN 2015. THE CAUSE OF FRACTURE WAS MOST LIKELY LACK OF BONY SUPPORT OF THE SHIELD, RESULTING IN BENDING STRESS AND, IN CASE OF ADIPOSITAS PERMAGNA MATERIAL FATIGUE. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2022. A REVISION SURGERY WAS NECESSARY. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4). INVOLVED COMPONENTS NR386K - ENDURO FEMUR SP:ACER POST/DIST F3 4X4MM - LOT 52113336. NR293K - FEMUR EXTENS.STEM 6° D18X77MM CEMENTED - LOT 52135389. NR400K - NUT F/FEMUR EXTENS.STEM ALL SIZES NEUTR. - LOT 52135289. NB013K - ENDURO TIBIAL COMP.OFFSET CEMENTED T3 - LOT 52159428. NB067K - ENDURO TIBIA HEMI-WEDGE T3 12MM RM/LL - LOT 51760228. NB075K - ENDURO TIBIA HEMI-WEDGE T3 4MM RL/LM - LOT 52107302. NR193K - TIBIA OFFSET STEM D18X52MM CEMENTED - LOT 52137131. NR890M - ENDURO MENI
Patient problems: Failure of Implant
MAUDE report 13559429 ↗InjuryFeb 1, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED TO AESCULAP AG THAT AN ENDURO FEMORAL COMPONENT CEMENTED F3R (PART # NB019K) WAS USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE ENDURO UNCOUPLED WITH LOCKING NUT AND WAS LYING FREELY IN THE JOINT. THE PATIENT UNDERWENT A REVISION PROCEDURE ON AN UNKNOWN DATE. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION SURGERY. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4). ASSOCIATED MEDWATCH-REPORTS: (400531692 - NB019K) 9610612-2021-00676 (400530846 - NR891M) INVOLVED COMPONENT: NR891M (ENDURO MENISCAL COMPONENT F3 12MM - LOT 52095496).
Patient problems: Failure of Implant
MAUDE report 13416980 ↗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 ↗InjuryOct 28, 2021Mechanical Problem; Mechanical Problem
CORRECTION: NR891M - ENDURO MENISCAL COMPONENT F3 12MM. WAS CHANGED FROM LEADING MATERIAL TO INVOLVED COMPONENT. ASSOCIATED MEDWATCH-REPORTS: 9610612-2021-00813 (400531692 - NB019K) 9610612-2021-00676 (400530846 - NR891M).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12711948 ↗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 ↗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 ↗MalfunctionMar 16, 2021Lack of Maintenance Documentation or Guidelines; Lack of Maintenance Documentation or Guidelines
THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11497292 ↗
Other Aesculap AG products
All Aesculap AG devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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