BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PS LIPPED TIBIA INSERT SM 9

    MDR report key: 2032681 · Received March 17, 2011

    Report

    Report Number
    9616680-2011-00141
    Event Type
    Injury
    Date Received
    March 17, 2011
    Date of Event
    February 28, 2011
    Report Date
    March 4, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    JWH
    PMA / PMN Number
    K012172
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "THE SURGEON NOTICED THE LOOSENED SCREW ON THE X-RAY AND AN ARTHROSCOPY. HE IS PLANNING A REVISION SURGERY AT THE END OF (B)(6)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PS LIPPED TIBIA INSERT SM 9 IMPLANT JWH STRYKER ORTHOPAEDICS CORK NA 210882

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention