BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYSORB SIZE 1

    MDR report key: 1033783 · Received April 25, 2008

    Report

    Report Number
    1219930-2008-00327
    Event Type
    Injury
    Date Received
    April 25, 2008
    Date of Event
    January 8, 2008
    Report Date
    April 3, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GAM
    PMA / PMN Number
    K963253
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORT SENT: 04/25/2008.

    Description of Event or Problem · 1

    PROCEDURE TYPE: TOTAL ENDO HIP-PROSTHESIS. ACCORDING TO THE REPORTER: THERE WAS A "DEEP INFECT WITH INFECT OF THE IMPLANTED OSTEO-SYNTHETIC MATERIAL. TWO REVISION SURGERIES ON THE HIP WERE NECESSARY. INDICATION COX ARTHROSIS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLYSORB SIZE 1 ABSORBABLE SYNTHETIC SUTURES GAM NORTH HAVEN - USS A7H306

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R