AS NR437ZRecalls & reported problems
Aesculap AG · AS FEMUR EXTENS.STEM 5° D17X177 CEM.LESS · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046963176662), received between Apr 1, 2025 and Apr 1, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Mechanical Problem” (1 report).
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
- Mechanical Problem1
Patient problems
- Loss of Range of Motion1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 1, 2025Mechanical Problem; Mechanical Problem
IT WAS REPORTED TO AESCULAP INC. THAT A AS COLUMBUS REV F FEMUR CEMENTED F6R (PART# NR016Z) WAS IMPLANTED ON (B)(6) 2021. ACCORDING TO THE COMPLAINT DESCRIPTION, A SURGERY TO REPLACE THE POLYETHYLENE COMPONENT(S) HAD BEEN PLANNED. DEBRIDEMENT OF SCARRING ON THE RIGHT KNEE WOULD ALSO BE PERFORMED. THE PATIENT EXPERIENCED DECREASED RANGE OF MOTION IN THE RIGHT KNEE AND PAIN. THE POLYETHYLENE REPLACEMENT WOULD LIKELY BE SMALLER IN SIZE. THE PROCEDURE WAS PLANNED FOR (B)(6) 2025. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE XC 100038781 CC 400702999. ASSOCIATED MEDWATCH REPORTS 3005673311-2025-00010. 3005673311-2025-00011. 3005673311-2025-00012. 3005673311-2025-00013. 3005673311-2025-00014. 3005673311-2025-00015. .. 3005673311-2025-00017. 3005673311-2025-00018.
Patient problems: Loss of Range of Motion
MAUDE report 21741261 ↗
Other PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER devices
- ELEOS™ 25001208EOnkos Surgical, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER3 deaths193 reports
- ELEOS™ THSMWRS01MOnkos Surgical, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER190 reports
- "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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