BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP RVRS 25MM BSPLT HA+ADPTR

    MDR report key: 8655571 · Received May 30, 2019

    Report

    Report Number
    0001825034-2019-02360
    Event Type
    Injury
    Date Received
    May 30, 2019
    Report Date
    May 30, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    K120121
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDRS WERE SUBMITTED FOR THIS EVENT. PLEASE SEE REPORTS: 0001825034 - 2019 - 00114, 0001825034 - 2019 - 00116, 0001825034 - 2019 - 00121, 0001825034 - 2019 - 00122. UDI: (B)(4). CONCOMITANT MEDICAL PRODUCTS: PRODUCT, LOT, DESCRIPTION: 010000589, LOT 863250, COMP RVRS 25MM BSPLT HA+ADPTR; 115316, LOT 956630, COMP RVRS SHLDR GLNSP +6 36MM; 113607, LOT 553780, COMP PRIMARY STEM 7MM MICRO; 115370, LOT 543710 COMP RVS TRAY CO 44MM. NO DEVICE WAS RETURNED FOR EVALUATION. REVIEW OF PROVIDED PATIENT MEDICAL RECORDS CONFIRMS THE REPORTED PATIENT BONE HAIRLINE FRACTURE AS WELL A HISTORY OF DISLOCATION. REVIEW OF DEVICE HISTORY RECORDS IDENTIFIED NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. ROOT CAUSE IS UNKNOWN. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED IN LITIGATION THE PATIENT HAS ONGOING PAIN, LIMITED MOBILITY OF HER LEFT SHOULDER, AXILLARY NERVE DEFICIT, LEFT BRACHIAL PLEXOPATHY, DELTOID WEAKNESS AND A HAIRLINE CRACK IN HER ANTERIOR HUMERAL CORTEX. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449538 COMP RVRS 25MM BSPLT HA+ADPTR PROSTHESIS, EXTREMITY KWS ZIMMER BIOMET, INC. 790140

    Patients

    Seq Age Sex Outcome Treatment
    1 Other