BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AS UNIVATION XF FEMUR CEMENTED F3 LM

    MDR report key: 11254365 · Received January 29, 2021

    Report

    Report Number
    9610612-2020-00997
    Event Type
    Injury
    Date Received
    January 29, 2021
    Report Date
    April 16, 2021
    Manufacturer
    AESCULAP AG
    Product Code
    HRY
    UDI-DI
    04046964053641
    PMA / PMN Number
    K131167
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: AS OF THE DATE OF THIS REPORT THE COMPLAINT PRODUCT WAS NOT PROVIDED FOR INVESTIGATION. THEREFORE, A THOROUGH INVESTIGATION IS NOT POSSIBLE. BATCH HISTORY REVIEW: THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS HAVE BEEN CHECKED FOR THE AVAILABLE LOT NUMBER AND WERE FOUND TO BE ACCORDING TO OUR SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. REVIEW OF THE COMPLAINT HISTORY REVEALED THAT NO SIMILAR COMPLAINTS HAVE BEEN FILED AGAINST PRODUCTS FROM THIS BATCH NUMBER. CONCLUSION AND MEASURES / PREVENTIVE MEASURES: BASED UPON THE INVESTIGATION RESULTS A CLEAR ROOT CAUSE CONCLUSION CANNOT BE DRAWN. THERE IS NO INDICATION FOR A MATERIAL-, MANUFACTURING- OR DESIGN-RELATED FAILURE. IN THE EVENT THAT THE COMPLAINT PRODUCT WILL BE PROVIDED FOR INVESTIGATION IN THE FUTURE, AN UPDATE OF THIS REPORT WILL BE PROVIDED UNSOLICITED. THE UNIVATION DEVICES WERE AFFECTED IN A RECALL INITIATED RECENTLY.

    Description of Event or Problem · 0

    ASSOCIATED MEDWATCH-REPORTS: 9610612-2020-00986 ((B)(4) NO165Z) INVOLVED COMPONENTS : NL473-UNIVATION F MENISCAL COMP.T4 RM/LM 7MM-51976008.

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    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 1468 DAYS AFTER THE PRIMARY SURGERY DUE TO IMPLANT LOOSENING. 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). ASSOCIATED MEDWATCH-REPORTS: 9610612-2020-00986 ((B)(4)). INVOLVED COMPONENTS NL473-UNIVATION F MENISCAL COMP.T4 RM/LM 7MM-51976008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148662 AS UNIVATION XF FEMUR CEMENTED F3 LM PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER HRY AESCULAP AG NO187Z 52024177 04046964053641

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention NL473-51976008.| NL473-51976008.