BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT PSL HA CLUSTER 54 MM

    MDR report key: 2002468 · Received February 16, 2011

    Report

    Report Number
    2249697-2011-00161
    Event Type
    Injury
    Date Received
    February 16, 2011
    Date of Event
    January 6, 2010
    Report Date
    January 20, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K983382
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFO BECOMES AVAILABLE, THEN IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: "THE PT IS EXPERIENCING PAIN FROM HER PRIMARY SURGERY. SALES REP CALLED OPERATING ROOM ASSISTS AND WANTED TO KNOW IF CATALOG #542-11-54F (LOT CODE MEPAWJ) WAS PART OF THE LIMITED SERIES OF PSL SHELLS THAT WERE INVOLVED WITH OUR 2008 TRIDENT RECALL. AN E-MAIL WAS SENT TO REGULATORY COMPLIANCE TO FOLLOW WITH REP. REP STATED THAT REGULATORY DID CHECK THE LOT CODE AND IT WAS NOT AFFECTED BY THE RECALL. REP WOULD LIKE TO HAVE A PER GENERATED AND A LETTER FOR DOCTOR ADVISING THAT THIS PARTICULAR LOT CODE FOR THE PSL SHELL WAS NOT AFFECTED BY THE 2008 TRIDENT RECALL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT PSL HA CLUSTER 54 MM IMPLANT MEH STRYKER ORTHOPAEDICS MAHWAH NA MEPAWJ

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other| R