BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIO-MOD ST.12X115 W/ALIGN HOLE

    MDR report key: 9601621 · Received January 17, 2020

    Report

    Report Number
    0001825034-2020-00311
    Event Type
    Injury
    Date Received
    January 17, 2020
    Date of Event
    December 10, 2019
    Report Date
    February 10, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HSD
    PMA / PMN Number
    K030710
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE REPORTED EVENT WAS CONFIRMED BY REVIEW OF PICTURES. THE PHOTOS OF EXPLANTED DEVICES IDENTIFIED THAT THEY ARE COVERED WITH BLOOD AND TISSUE. THE GLENOID WAS COVERED WITH CEMENT. VISUAL INSPECTION IDENTIFIED SCRATCHES ON THE HUMERAL AND HEAD. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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

    NO ADDITIONAL EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 113764 BIO-MOD HUM HEAD 44DIAX17MM 065770; 113849 BIO-MOD GLEN 4MM ALLPOLY SMAL UNKNOWN. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE WAS REQUESTED BUT NOT RETURNED BY THE HOSPITAL. 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: 0001825034-2020-00309, 0001825034-2020-00310.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT AN INITIAL TSA. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY NINE YEARS POST-IMPLANTATION DUE TO PAIN AND LOSS OF FUNCTION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62753 BIO-MOD ST.12X115 W/ALIGN HOLE PROSTHESIS, SHOULDER HSD ZIMMER BIOMET, INC. 436310

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R