BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE SRS MOD RGX AUG - SM

    MDR report key: 8688783 · Received June 11, 2019

    Report

    Report Number
    0001825034-2019-02523
    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 211278, LOT 672550, SUPER EAS HUMERAL HEAD 48X19MM. 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 0001825034-2019-02524 0001825034-2019-02525 0001825034-2019-02526. DEVICE EVALUATED BY MFR: 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
    481660 COMPREHENSIVE SRS MOD RGX AUG - SM PROSTHESIS, SHOULDER KWT ZIMMER BIOMET, INC. N/A 216410

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention