BEUDAMED
    FDA Adverse Event Other Summary report: N

    RSP SHOULDER

    MDR report key: 3122606 · Received May 15, 2013

    Report

    Report Number
    1644408-2013-00283
    Event Type
    Other
    Date Received
    May 15, 2013
    Date of Event
    May 9, 2013
    Report Date
    May 9, 2013
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    PMA / PMN Number
    K051075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - THIS PT HAS HAD A RECURRENT INFECTION POST-OPERATIVELY BELIEVED TO BE LINKED TO A TOOTH ABSCESS THAT OCCURRED FOLLOWING HIS SURGERY. THE PT WAS BROUGHT IN FOR AN IRRIGATION AND DEBRIDEMENT. THE GLENOSPHERE AND POLY INSERT WERE EXCHANGED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214693 RSP SHOULDER STANDARD HUMERAL SOCKET INSERT KWS ENCORE MEDICAL, L.P. 855C1167

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention (B)(4), LOT 862C1186