BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK STD CEMENTED FEMUR SIZE 3 LEFT

    MDR report key: 4743182 · Received April 29, 2015

    Report

    Report Number
    3005180920-2015-00073
    Event Type
    Injury
    Date Received
    April 29, 2015
    Report Date
    July 22, 2015
    Product Code
    JWH
    PMA / PMN Number
    K090988
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ON 24 JUNE 2015, IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION COLLECTED DURING THE INVESTIGATION, ALREADY REPORTED IN THE INITIAL REPORT. ON 26 JUNE 2015, THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON (B)(4) 2015: LOT 122099: (B)(6) FEMURS PRODUCED AND RELEASED ON (B)(4) 2012. NO ANOMALIES FOUND. TO DATE, (B)(4) ITEMS OF THE LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR ISSUE. ON (B)(6) 2015, THE MEDICAL AFFAIRS DIRECTOR MADE THE FOLLOWING ANALYSIS: FROM THE X-RAY PROVIDED, I CANNOT IDENTIFY ANY POSSIBLE CAUSE FOR THE FAILURE. THE IMPLANT SEEMS PERFECTLY POSITIONED AND ALIGNED. I CANNOT SEE ANY INDICATION THAT IT WOULD BE PAINFUL AND GET LOOSE. POSSIBLY AN UNUSUAL SHAPE OF THE PATELLA, BUT OF COURSE NOTHING CONCLUSIVE, AND THE PATELLA HAS NOT BEEN REPLACED. FOR ME, THE ROOT CAUSE IS TOTALLY UNK, BASED ON THE SUPPLIED DATA.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280667 GMK STD CEMENTED FEMUR SIZE 3 LEFT FIXED TIBIAL TRAY JWH

    Patients

    Seq Age Sex Outcome Treatment
    1