BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE SHOULDER HUMERAL FRACTURE STEM

    MDR report key: 6358437 · Received February 24, 2017

    Report

    Report Number
    0001825034-2017-00926
    Event Type
    Injury
    Date Received
    February 24, 2017
    Date of Event
    January 26, 2017
    Report Date
    September 25, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWT
    PMA / PMN Number
    PK023063
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THIS REPORT IS NUMBER 1 OF 5 MDR'S FILED FOR THE SAME PATIENT (REFERENCE 0001825034-2017-00919 / 00921 / 00922 / 00936).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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 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. FIXED LOCKING SCREW, CATALOG#: 180555, LOT#: 264120. 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. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT 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. THE SURGEON REMOVED THE IMPLANTS AND REPLACED THEM WITH CEMENT SPACER MOLDS.

    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
    140798 COMPREHENSIVE SHOULDER HUMERAL FRACTURE STEM PROSTHESIS, SHOULDER KWT BIOMET ORTHOPEDICS NA 430310

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R