AS univation® XF NO187ZRecalls & reported problems
Aesculap AG · AS UNIVATION XF FEMUR CEMENTED F3 LM · Class 2 · Implant
All models of AS univation XF (14)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04046964053641), received between Jan 29, 2021 and Mar 2, 2022 — classified as 2 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 18, 2026.
Most reported problems
Device problems
- Loosening of Implant Not Related to Bone-Ingrowth2
Patient problems
- Failure of Implant2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 2, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED TO AESCULAP AG THAT AN AS UNIVATION XF FEMUR CEMENTED F3 LM (PART # NO187Z) WAS IMPLANTED DURING A PRIMARY PROCEDURE PERFORMED ON OCTOBER 5, 2020. ACCORDING TO THE COMPLAINANT, FOLLOWING IMPLANTATION, THE PATIENT EXPERIENCED PAIN. RADIOGRAPHIC AND SCINTIGRAPHIC EXAMINATION CONFIRMED LOOSENING OF IMPLANT. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022 WHICH REVEALED A COMPLETE LOOSENING, BOTH TIBIALLY AND FEMORALLY, IN THE PROSTHESIS/CEMENT INTERFACE. SO FAR, NO EVIDENCE OF INFECTION. THE COMPLAINT DEVICE WAS 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 XC 100030121; CC 400544176. ASSOCIATED MEDWATCH-REPORTS: 9610612-2022-00037 (400544175 - NO164Z). 9610612-2022-00038 (400544176 - NO187Z). INVOLVED COMPONENTS: NL472 - UNIVATION F MENISCAL COMP.T3 RM/LM 7MM - LOT 52592618.
Patient problems: Failure of Implant
MAUDE report 13654561 ↗InjuryJan 29, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
ASSOCIATED MEDWATCH-REPORTS: 9610612-2020-00986 ((B)(4) NO165Z) INVOLVED COMPONENTS : NL473-UNIVATION F MENISCAL COMP.T4 RM/LM 7MM-51976008.
Patient problems: Failure of Implant
MAUDE report 11254365 ↗
Other PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER devices
- R3 71363077Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER461 reports
- NA 71364009Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER174 reports
- JOURNEY 74012416Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER163 reports
- JOURNEY 74012415Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER163 reports
- JOURNEY 74012414Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER129 reports
- GENESIS II 71440194Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER114 reports
- GENESIS II 71440842Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER113 reports
- JOURNEY 74018901Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER106 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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