AS univation® XF NO165ZRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04046964053764), received between Nov 9, 2020 and May 20, 2021 — classified as 4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMay 20, 2021Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH NO165Z - AS UNIVATION XF TIBIA CEMENTED T4 LM. ACCORDING TO THE COMPLAINT DESCRIPTION, THERE WAS A POSTOPERATIVE KNEE INFECTION. THE PATIENT REQUIRED A POLY SWAP. DURING THE REPLACEMENT PROCEDURE, IT WAS NOTED THAT THE "FEMUR FELL OFF". A REVISION SURGERY WAS NECESSARY. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE. THE ADVERSE EVENT IS FILED UNDER (B)(4). ASSOCIATED MEDWATCH REPORTS: 9610612-2021-00332 ((B)(4)+ NO188Z). INVOLVED COMPONET: NL473 -UNIVATION F MENISCAL COMP.T4 RM/LM 7MM - 52047925.

  Patient problems: Failure of Implant

  MAUDE report 11856559 ↗
• InjuryMar 7, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  ASSOCIATED MEDWATCH-REPORTS: 9610612-2021-00114 ((B)(4) NO188Z); 9610612-2021-00115 ((B)(4) NO165Z). INVOLVED COMPONENTS (AUFFÜHREN IN D11 + C2). NL479-UNIVATION F MENISCAL COMP.T4 RM/LM 8MM-52462745.

  Patient problems: Failure of Implant

  MAUDE report 11426346 ↗
• InjuryJan 29, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  ASSOCIATED MEDWATCH-REPORTS: 9610612-2020-00997 ((B)(4)- NO187Z). INVOLVED COMPONENTS: NL473-UNIVATION F MENISCAL COMP.T4 RM/LM 7MM-51976008.

  Patient problems: Failure of Implant

  MAUDE report 11253409 ↗
• InjuryNov 9, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH KNEE COMPONENTS. AS A RESULT OF HAVING THE PRODUCT IMPLANTED THE PATIENT HAS EXPERIENCED UNKNOWN CLAIMS, BUT IT IS KNOWN THAT IT RESULTED IN A REVISION SURGERY. THE PRIMARY SURGERY OCCURRED ON (B)(6) 2016 AND THE REVISION SURGERY OCCURED ON (B)(6) 2017. CEMENT USED: ZIMMER PALACOS CEMENT. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED AT THIS TIME, IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE COMPLAINT WILL BE UPDATED ACCORDINGLY. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER REFERENCE (B)(4). INVOLVED COMPONENTS: NO165Z (TIBIAL CEMENTED T4 LM), NO188Z (FEMUR CEMENTED F4 LM), NL473 (PE INSERT T4 RM/LM 7MM), NX044 (UNIVERSAL PATELLA P4), NP583R (THREADED PIN, HEADLESS 3.2MMX63MM). ASSOCIATED MEDWATCHES: 2916714-2020-00571, 2916714-2020-00572, 2916714-2020-00573, 2916714-2020-00574.

  Patient problems: Insufficient Information

  MAUDE report 10813254 ↗