BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP RVRS 25MM BSPLT HA+ADPTR

    MDR report key: 8784370 · Received July 12, 2019

    Report

    Report Number
    0001825034-2019-02973
    Event Type
    Injury
    Date Received
    July 12, 2019
    Date of Event
    March 15, 2019
    Report Date
    September 19, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    K182534
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS NOT CONFIRMED. VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED SCUFFING AND SCRATCHES THAT CAN BE FELT ON THE OUTSIDE RADIUS OF THE TAPER ADAPTER. THERE IS WEAR IDENTIFIED ON THE POLY. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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 EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 115310, COMP RVRS SHLDR GLNSP STD 36MM, 752660; 115370, COMP RVS TRAY CO 44MM, 244720; XL-115363, ARCOM XL 44-36 STD HMRL BRNG, 447190. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-02972. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT'S SHOULDER WAS REVISED DUE TO DISASSOCIATION. IT WAS NOTED THAT GLENOSPHERE DISASSOCIATED FROM BASEPLATE. ATTEMPTS WERE MADE TO GAIN INFORMATION, HOWEVER NO ADDITIONAL INFORMATION WAS MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578310 COMP RVRS 25MM BSPLT HA+ADPTR PROSTHESIS, SHOULDER KWS ZIMMER BIOMET, INC. N/A 902160

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R