BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PCA MTK PATELLAR MEDIUM OBSOLETE PRODUCT NO

    MDR report key: 1132045 · Received August 21, 2008

    Report

    Report Number
    2249697-2008-00236
    Event Type
    Injury
    Date Received
    August 21, 2008
    Date of Event
    March 1, 2008
    Report Date
    July 30, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    HTG
    PMA / PMN Number
    K864632
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. NO EVAL WILL BE PERFORMED. IF DEVICE BECOMES AVAILABLE WITH ADD'L INFO, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "UPON PT COMING TO DR'S OFFICE PT NOTICED SLIGHT NOISE AND PAIN IN RIGHT KNEE. TOTAL KNEE REPLACEMENT WAS DONE IN 1993 BY SAME PHYSICIAN. SURGERY WAS SCHEDULED BUT DELAYED DUE TO CARDIAC CLEARANCE. SURGERY PERFORMED FINDING "BLACK" TISSUE STAINING DUE TO METAL TO METAL CONTACT OF PATELLA WHICH HAD POLY EVULSED FROM SUBSTRATE. METAL BACK ALSO CRACKED. OF NOT ALSO POLY INSERT SHOWS PELAMINATION-BUT MAYBE DUE TO 15 YRS WEAR ON THIS PT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PCA MTK PATELLAR MEDIUM OBSOLETE PRODUCT NO IMPLANT HTG STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention