AS NR178ZRecalls & reported problems
Aesculap AG · AS TIBIA OFFSET STEM D18X92 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 04046963176334), received between Oct 14, 2024 and Oct 14, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (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
- Patient-Device Incompatibility1
Patient problems
- Failure of Implant1
Recent adverse event reports
The 1 most recent of 1 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 TIBIA OFFSET STEM D18X92 CEMENTLESS (PART# NR178Z) 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 (B)(4). 2916714-2024-00151 (AIC REFERENCE NO. (B)(4)), 2916714-2024-00152 (AIC REFERENCE NO. (B)(4)), 2916714-2024-00153 (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 20446694 ↗
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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