BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP AUG MINI BSPLT W TPR SM

    MDR report key: 8270183 · Received January 23, 2019

    Report

    Report Number
    0001825034-2019-00214
    Event Type
    Injury
    Date Received
    January 23, 2019
    Date of Event
    December 29, 2018
    Report Date
    March 12, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION RECEIVED: UDI: (B)(4). THE COMPLAINT CANNOT BE CONFIRMED AS THE MEDICAL RECORDS WERE NOT PROVIDED. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. A DEFINITE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. 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

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL REVERSE SHOULDER ARTHROPLASTY AND UNDERWENT A REVISION DUE TO INFECTION APPROXIMATELY ONE MONTH POST IMPLANTATION. PATIENT EXPERIENCED HEMATOMA POST PRIMARY SURGERY NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 115320 COMP RVRS SHLDR GLNSP STD 41MM 982880; 115370 COMP RVS TRAY CO 44MM 430240; 115396 COMP RVS CNTRL 6.5X30MM ST/RST 512120; UNKNOWN HUMERAL STEM. FOREIGN- (B)(6). THE COMPLAINT IS UNDER INVESTIGATION. ONCE THE INVESTIGATION IS COMPLETED A FOLLOW UP REPORT WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 -2019 -00213; 0001825034 -2019 -00215; 0001825034 -2019 -00216.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL REVERSE SHOULDER ARTHROPLASTY AND UNDERWENT A REVISION DUE TO HEMATOMA APPROXIMATELY ONE MONTH POST IMPLANTATION. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64488 COMP AUG MINI BSPLT W TPR SM PROSTHESIS, SHOULDER KWS ZIMMER BIOMET, INC. N/A 64027393

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R