BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYBRID ARCOM GLENOID BASE

    MDR report key: 6711003 · Received July 13, 2017

    Report

    Report Number
    0001825034-2017-04782
    Event Type
    Injury
    Date Received
    July 13, 2017
    Date of Event
    June 16, 2017
    Report Date
    July 13, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWS
    PMA / PMN Number
    PK060694
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT DEVICES ¿ COMPREHENSIVE SHOULDER SYSTEM STANDARD TAPER ADAPTOR CATALOG #: 118001 LOT #: 971510, COMPREHENSIVE SHOULDER SYSTEM MINI HUMERAL STEM CATALOG #: 113628 LOT #: 612000, COMPREHENSIVE SHOULDER SYSTEM MODULAR HEAD ¿ VARIABLE OFFSET CATALOG #: 113032 LOT #: 600060, HYBRID GLENOID REGENEREX POROUS TITANIUM GLENOID POST CATALOG #: PT-113950 LOT #: 953880. PRODUCT RETURN -THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE IMPLANTS WERE DISCARDED. THE COMPLAINT SAMPLE WAS EVALUATED THROUGH A DEVICE HISTORY RECORD REVIEW AND COMPLAINT HISTORY SEARCH AND THE REPORTED EVENT COULD NOT BE CONFIRMED. NO DEVICES OR PHOTOS WERE RECEIVED; THEREFORE THE CONDITION OF THE DEVICE IS UNKNOWN. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE IDENTIFIED. A REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTIONS ARE REQUIRED. A ROOT CAUSE WAS UNABLE TO BE DETERMINED WITH THE INFORMATION PROVIDED. THIS REPORT IS NUMBER 3 OF 5 MDRS FILED FOR THE SAME PATIENT (REFERENCE (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT UNDERWENT RIGHT SHOULDER ARTHROPLASTY REVISION DUE TO A ROTATOR CUFF TEAR FIVE (5) MONTHS POST-OPERATIVELY. THE PATIENT WAS CONVERTED TO A REVERSE TOTAL SHOULDER. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.ATTEMPTS HAVE BEEN MADE TO RETRIEVE ADDITIONAL INFORMATION, BUT NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492205 HYBRID ARCOM GLENOID BASE PROSTHESIS, SHOULDER KWS BIOMET ORTHOPEDICS N/A 239910

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R SEE H10 NARRATIVE