AS univation® XF NO188ZRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04046964053658), received between Nov 9, 2020 and Apr 22, 2021 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryApr 22, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH AN AS UNIVATION XF FEMUR. 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 AAG REFERENCE (B)(4).

  Patient problems: Post Operative Wound Infection

  MAUDE report 11712113 ↗
• InjuryApr 22, 2021Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH NO188Z - AS UNIVATION XF FEMUR CEMENTED F4 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 AAG REFERENCE (B)(4).

  Patient problems: Failure of Implant; Post Operative Wound Infection

  MAUDE report 11711665 ↗
• InjuryMar 7, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH NO188Z-AS UNIVATION XF FEMUR CEMENTED F4 LM. ACCORDING TO THE COMPLAINT DESCRIPTION, THE UNIVATION X NO188Z AND NO165Z IMPLANTS HAVE LOOSENED. NO CEMENT ADHESION CAN BE OBSERVED ON THE IMPLANTS. A REVISION SURGERY WAS NECESSARY. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE / WAS NOT AVAILABLE. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4). ASSOCIATED MEDWATCH-REPORTS: 9610612-2021-00114 (400502135 NO188Z), 9610612-2021-00115 (400502136 NO165Z). INVOLVED COMPONENTS (AUFFÜHREN IN D11 + C2) NL479-UNIVATION F MENISCAL COMP.T4 RM/LM 8MM-52462745.

  Patient problems: Failure of Implant

  MAUDE report 11426347 ↗
• 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 (B)(4). INVOLVED COMPONENTS: NL474. ASSOCIATED MEDWATCH-REPORTS: 9610612-2021-00023 (400499147 (B)(4)).

  Patient problems: Arthritis

  MAUDE report 11245985 ↗
• 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 OCCURRED 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: 2916714-2020-00570, 2916714-2020-00572, 2916714-2020-00573, 2916714-2020-00574.

  Patient problems: Insufficient Information

  MAUDE report 10813334 ↗