BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AS UNIVATION XF FEMUR CEMENTED F4 LM

    MDR report key: 10649925 · Received October 8, 2020

    Report

    Report Number
    9610612-2020-00680
    Event Type
    Injury
    Date Received
    October 8, 2020
    Date of Event
    September 9, 2020
    Report Date
    November 20, 2020
    Manufacturer
    AESCULAP AG
    Product Code
    HRY
    PMA / PMN Number
    K131167
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: VISUAL INVESTIGATION: THE DEVICE WAS NOT RETURNED. THEREFORE A INVESTIGATION OF THE DEVICE ITSELF IS NOT POSSIBLE. BATCH HISTORY REVIEW: THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS (DHR) HAVE BEEN CHECKED FOR ALL AVAILABLE LOT NUMBERS AND THE PRODUCTS FOUND TO BE ACCORDING TO OUR SPECIFICATION VALID AT THE TIME OF PRODUCTION. THERE ARE NO SIMILAR COMPLAINTS AGAINST THE SAME LOT NUMBER(S) WITH THIS ERROR PATTERN. CONCLUSION AND MEASURES: BASED ON THE PROVIDED INFORMATION AND WITHOUT A PRODUCT FOR INVESTIGATION, A CLEAR CONCLUSION CAN NOT BE DRAWN. BASED ON THE INVESTIGATIONS AND RESULTS OF THE 8D REPORT FURTHER EXAMINATIONS NEEDS TO BE DONE UNDER PSC 2020-045.

    Description of Event or Problem · 0

    THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4). ASSOCIATED MEDWATCH-REPORTS: 9610612-2020-00680 ((B)(6) + NO188Z), 9610612-2020-00681 ((B)(6) + NO164Z). INVOLVED COMPONENTS: NL472 - UNIVATION F MENISCAL COMP.T3 RM/LM 7MM - BATCH 52520450.

    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 THAT THERE WAS AN ISSUE WITH A UNIVATION FEMUR PROTHESIS. ACCORDING TO THE COMPLAINT DESCRIPTION THE IMPLANTS LOOSENED 10 MONTH AND 10 DAYS POST SURGERY. INITIAL SURGERY DATE: (B)(6) 2019, LEFT SIDE. REVISION NOT YET PERFORMED. A PERMANENT IMPAIRMENT FOR THE PATIENT WAS CURRENTLY REPORTED. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4). ASSOCIATED MEDWATCH-REPORTS: 9610612-2020-00680 (400487359 + NO188Z). 9610612-2020-00681 (400487360 + NO164Z). INVOLVED COMPONENTS: NL472 - UNIVATION F MENISCAL COMP.T3 RM/LM 7MM - BATCH 52520450.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1112039 AS UNIVATION XF FEMUR CEMENTED F4 LM FEMUR IMPLANTS UNIVATION HRY AESCULAP AG NO188Z 52511975

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Disability NL472 - BATCH 52520450