BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE FIXED LOCKING SCREW

    MDR report key: 6891291 · Received September 25, 2017

    Report

    Report Number
    0001825034-2017-07340
    Event Type
    Injury
    Date Received
    September 25, 2017
    Date of Event
    January 26, 2017
    Report Date
    September 25, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    PK132239
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). CONCOMITANT MEDICAL PRODUCT: COMPREHENSIVE REVERSE SHOULDER HUMERAL BEARING, CATALOG#: XL-115364, LOT#: 855080; COMPREHENSIVE REVERSE SHOULDER GLENOSPHERE, CATALOG#: 115316, LOT#: 502920; COMPREHENSIVE REVERSE SHOULDER GLENOSPHERE MINI BASEPLATE W/ TAPER ADAPTER, CATALOG#: 010000589; COMPREHENSIVE SHOULDER HUMERAL FRACTURE STEM, CATALOG#: 12-113562, LOT#: 430310; COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY W/ LOCKING RING, CATALOG#: 115370, LOT#: 148930; COMPREHENSIVE REVERSE SHOULDER GLENOSPHERE, CATALOG#: 115310, LOT#: 196530; FIXED LOCKING SCREW, CATALOG#: 180550, LOT#: 914840; COMPREHENSIVE REVERSE FIXED LOCKING SCREW, CATALOG#: 180552, LOT#: 186760; COMPREHENSIVE REVERSE CENTRAL SCREW, CATALOG#: 115397, LOT#: 327030; COMPREHENSIVE REVERSE STEINMANN, CATALOG#: 405800, LOT#: 423030; COMPREHENSIVE REVERSE DRILL, CATALOG#: 405889, LOT#: 977480; COMPREHENSIVE REVERSE DRILL, CATALOG #: 405883, LOT#: 328460. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-00919 / 00921 / 00922 / 00926 / 00936 / 07338 / 07339 / 07340 / 07342. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION(S) IS/ARE REQUIRED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT 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 · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT SHOULDER ARTHROPLASTY REVISION DUE TO INFECTION 5 MONTHS POST-IMPLANTATION. THE SURGEON REMOVED THE IMPLANTS AND REPLACED THEM WITH CEMENT SPACER MOLDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669790 COMPREHENSIVE FIXED LOCKING SCREW PROSTHESIS, SHOULDER KWS ZIMMER BIOMET, INC. N/A 264120

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R