BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PT HYBRID GLENOID POST REGENEREX POROUS TITANIUM CONSTRUCT

    MDR report key: 6568902 · Received May 16, 2017

    Report

    Report Number
    0001825034-2017-03198
    Event Type
    Injury
    Date Received
    May 16, 2017
    Date of Event
    April 13, 2017
    Report Date
    November 7, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWS
    PMA / PMN Number
    PK060694
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICES: SM HYBRID GLENOID BASE 4MM CATALOG#: 113952 LOT#: 232690, UNKNOWN HUMERAL HEAD CATALOG#: UNKNOWN LOT#: UNKNOWN. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. 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.

    Additional Manufacturer Narrative · 1

    CMP-(B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED [AS IT WAS DISCARDED AT THE HOSPITAL] TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-03198 AND 0001825034-2017-03199.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT SHOULDER ARTHROPLASTY REVISION DUE TO BREAKAGE OF THE GLENOID POST FROM THE GLENOID COMPONENT APPROXIMATELY 5 YEARS POST-IMPLANTATION. THE HUMERAL HEAD, GLENOID, AND GLENOID POST WERE REMOVED AND THE PATIENT WAS CONVERTED TO A HEMI SHOULDER BY PLACING A NEW HUMERAL HEAD AND PACKING BONE GRAFT INTO THE GLENOID DEFICIT. THE SURGEON SUSPECTS THE GLENOID MAY HAVE LOOSENED, BUT THIS COULD NOT BE CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT SHOULDER ARTHROPLASTY REVISION DUE TO BREAKAGE OF THE GLENOID POST FROM THE GLENOID COMPONENT APPROXIMATELY 5 YEARS POST-IMPLANTATION. THE HUMERAL HEAD, GLENOID, AND GLENOID POST WERE REMOVED AND THE PATIENT WAS CONVERTED TO A HEMI SHOULDER. THE SURGEON SUSPECTS THE GLENOID MAY HAVE LOOSENED, BUT THIS COULD NOT BE CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350549 PT HYBRID GLENOID POST REGENEREX POROUS TITANIUM CONSTRUCT PROSTHESIS, SHOULDER KWS BIOMET ORTHOPEDICS N/A 793660

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R