AS NR171ZRecalls & reported problems
Aesculap AG · AS TIBIA OFFSET STEM D11X92 CEMENTLESS · 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 04046963176266), received between Nov 19, 2024 and Nov 19, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Failure of Implant1
- Implant Pain1
Recent adverse event reports
The 1 most recent of 1 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 TIBIA OFFSET STEM D11X92 CEMENTLESS (PART # NR171Z) 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 XC 100037637 CC (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)) 2916714-2024-00191 (AIC REFERENCE NO. (B)(4)).
Patient problems: Failure of Implant; Implant Pain
MAUDE report 20722556 ↗
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
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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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