BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP RVRS 25MM BSPLT HA+ADPTR

    MDR report key: 8270054 · Received January 23, 2019

    Report

    Report Number
    0001825034-2019-00122
    Event Type
    Injury
    Date Received
    January 23, 2019
    Report Date
    May 30, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    K120121
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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.

    Description of Event or Problem · 0

    NO FURTHER INFORMATION AVAILABLE AT THE TIME OF THIS REPORTING.

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDRS WERE SUBMITTED FOR THIS EVENT. PLEASE SEE REPORTS: 0001825034 - 2019 - 00113; 0001825034 - 2019 - 00114; 0001825034 - 2019 - 00116; 0001825034 - 2019 - 00121. UDI (B)(4). CONCOMITANT MEDICAL PRODUCTS: 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; XL-115363, LOT 435590, ARCOM XL 44-36 STD HMRL BRNG. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. DEVICE REMAINS IMPLANTED.

    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 REVISION HAS BEEN REPORTED. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65216 COMP RVRS 25MM BSPLT HA+ADPTR PROSTHESIS, EXTREMITY KWS ZIMMER BIOMET, INC. 863250

    Patients

    Seq Age Sex Outcome Treatment
    1 Other