AS univation® XF NO166ZRecalls & reported problems
Aesculap AG · AS UNIVATION XF TIBIA CEMENTED T5 LM · Class 2 · Implant
All models of AS univation XF (14)
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 04046964053771), received between Jan 28, 2021 and Jan 28, 2021 — 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.
Most reported problems
Device problems
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Arthritis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 28, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED TO AESCULAP INC. THAT A UNIVATION X UNICONDYLAR KNEE ARTHROPLASTY SYSTEM WAS IMPLANTED DURING A PRIMARY SURGERY PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE PATIENT UNDERWENT A REVISION SURGERY 1863 DAYS AFTER THE PRIMARY SURGERY DUE TO OSTEOARTHRITIS. THE DEVICE WAS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. THE SURGEON PROVIDED ADDITIONAL INFORMATION WHICH REVEALED THE FOLLOWING CEMENT TECHNIQUE: "CEMENT HOLES WERE DRILLED IN BOTH FEMUR AND TIBIA. CEMENT WAS APPLIED WITH FINGER PRESSURE TO THE BONE AND TO THE COMPONENTS. TIBIAL COMPONENT IMPACTED AND EXCESS CEMENT CLEARED. FEMORAL COMPONENT IMPACTED AND EXCESS CEMENT CLEARED. TRIAL SURFACE WAS PLACED AND KNEE BROUGHT INTO EXTENSION WITH TONGUE DEPRESSOR FOR PRESSURIZATION. CEMENT ALLOWED TO CURE PRIOR TO PLACING FINAL POLY." NO KNOWN PATIENT COMPLICATIONS FOLLOWING THE REVISION SURGERY. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE XC (B)(4). INVOLVED COMPONENTS: NL474. ASSOCIATED MEDWATCH-REPORTS: 9610612-2021-00024 ((B)(4) NO166Z).
Patient problems: Arthritis
MAUDE report 11245987 ↗
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 74012415Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER163 reports
- JOURNEY 74012416Smith & 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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