AS univation® XF NO164ZRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046964053757), received between Mar 2, 2022 and Mar 2, 2022 — 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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 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 TIBIA CEMENTED T3 LM (PART # NO164Z) WAS IMPLANTED DURING A PRIMARY PROCEDURE PERFORMED ON (B)(6) 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 (B)(4). ASSOCIATED MEDWATCH-REPORTS: ((B)(4) - NO164Z), 9610612-2022-00038 ((B)(4) - NO187Z). INVOLVED COMPONENTS: NL472 - UNIVATION F MENISCAL COMP.T3 RM/LM 7MM - LOT 52592618.

  Patient problems: Failure of Implant

  MAUDE report 13654593 ↗