BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE SRS SEAS HUMERAL HEAD

    MDR report key: 8688785 · Received June 11, 2019

    Report

    Report Number
    0001825034-2019-02524
    Event Type
    Injury
    Date Received
    June 11, 2019
    Date of Event
    May 13, 2019
    Report Date
    October 22, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWT
    PMA / PMN Number
    K111746
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). REPORTED EVENT WAS CONSIDERED AS THE MEDICAL RECORDS CONFIRMED THE PATIENT'S AILMENTS. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. 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 · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: REF: 211226, LOT: 938550, INTERCALARY SEGMENT 90MM; REF: 211258, LOT: 314970, MODULAR STEM 9X75MM; REF: 211228, LOT: 216410, REGENEREX AUGMENT SMALL; REF: 211223, LOT: 484220, PROXIMAL BODY 71MM; REF: B000-0185 LOT: 6M9704, STRYKER UNIVERSAL CEMENT RESTRICTOR; REF: 6197-1-001 LOT: TMZ046, ANTIBIOTIC SIMPLEX P QTY: 2. REPORT SOURCE: FOREIGN COUNTRY: (B)(6). 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 - 2019 - 02522, 0001825034 - 2019 - 02523, 0001825034 - 2019 - 02525, 0001825034 - 2019 - 02526. IMPLANTED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT PATIENT EXPERIENCED WOUND DEHISCENCE, NECROSIS, AND SUPERFICIAL INFECTION ONE MONTH POST INITIAL SURGERY. THE WOUND WAS CLOSED WITH SUTURE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481662 COMPREHENSIVE SRS SEAS HUMERAL HEAD PROSTHESIS, SHOULDER KWT ZIMMER BIOMET, INC. N/A 672550

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention