BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPR SRS MOD STEM - 12X100MM

    MDR report key: 8221614 · Received January 7, 2019

    Report

    Report Number
    0001825034-2018-11333
    Event Type
    Injury
    Date Received
    January 7, 2019
    Date of Event
    October 12, 2018
    Report Date
    January 23, 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 · 1

    UPON REASSESSMENT OF THE REPORTED EVENT BASED ON THE ADDITIONAL INFORMATION, IT WAS DETERMINED THAT THE PRODUCT IS NOT REPORTABLE. THE EVENT IS NOT PROCEDURE OR IMPLANT RELATED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 211225 COMPR SRS IC SEG - 60MM 875550, 110029938 COMPR SRS 50MM DST HUM BDY RT 213040, UNKNOWN NEXEL ULNAR COMPONENT, UNKNOWN NEXEL ULNAR ARTICULATION COMPONENT. FOREIGN- (B)(6). THE COMPLAINT IS UNDER INVESTIGATION. 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 - 2018 - 11332, 0001825034 - 2018 - 11334.

    Description of Event or Problem · 1

    NO ADDITIONAL INFORMATION IS AVAILABLE TO REPORT AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT AN INITIAL RIGHT DISTAL HUMERAL RESECTION WITH RECONSTRUCTION INVOLVING AN ELBOW ARTHROPLASTY, AND RECEIVED BLOOD TRANSFUSION DUE TO POSTOPERATIVE ANEMIA. IT WAS MENTIONED THAT THE EVENT IS PROCEDURE RELATED AND NOT DEVICE RELATED. NO OTHER ADDITIONAL INFORMATION IS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14740 COMPR SRS MOD STEM - 12X100MM PROSTHESIS, SHOULDER KWT ZIMMER BIOMET, INC. N/A 653050

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention