AS ENDURO NB018ZRecalls & reported problems
Aesculap AG · AS ENDURO FEMORAL COMPONENT CEMENTED F2R · Class 2 · Implant
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 04046963177546), received between Jun 6, 2023 and Oct 14, 2024 — classified as 3 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.
Reports received per month
Most reported problems
Device problems
- Loosening of Implant Not Related to Bone-Ingrowth2
- Patient-Device Incompatibility1
Patient problems
- Failure of Implant2
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryOct 14, 2024Patient-Device Incompatibility; Patient-Device Incompatibility
IT WAS REPORTED TO AESCULAP INC. THAT AN AS ENDURO FEMORAL COMPONENTS CEMENTED F2R (PART# NB018Z) WAS IMPLANTED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT THE IMPLANT WAS TOO TIGHT. REPORTEDLY THE PATIENT IS SCHEDULED FOR A REVISION SURGERY ON AN UNSPECIFIED DATE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET PROVIDED. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE XC (B)(4) (AIC REFERENCE NO. (B)(4) 2916714-2024-00152 (AIC REFERENCE NO. (B)(4) 2916714-2024-00153 (AIC REFERENCE NO. (B)(4) 2916714-2024-00154 (AIC REFERENCE NO. (B)(4) 2916714-2024-00155 (AIC REFERENCE NO. (B)(4) 2916714-2024-00156 (AIC REFERENCE NO. (B)(4) 2916714-2024-00157 (AIC REFERENCE NO. (B)(4) 2916714-2024-00158 (AIC REFERENCE NO. (B)(4)
Patient problems: Failure of Implant
MAUDE report 20447083 ↗InjuryJun 6, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
InjuryJun 6, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
INVOLVED COMPONENTS: NR410Z - AS FEMUR EXTENS.STEM 5° D20X117 CEM.LESS - LOT 52455976 NR592Z - AS ENDURO FEM.SPACER POST/DIST F2 12X4MM - LOT 52325498 NR882Z - AS ENDURO MENISCAL COMPONENT F2 14MM - LOT 52559347 NX045 - PATELLA 3-PEGS P5 - LOT 52431745 NR400Z - AS NUT F/FEMUR EXTENS.STEM ALL SZ.NEUTR. - LOT 52569541
Patient problems: Failure of Implant
MAUDE report 17073262 ↗
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- "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
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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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