BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFNA-II 012XS 130 DEGREES L170 TAN

    MDR report key: 2232604 · Received August 25, 2011

    Report

    Report Number
    8030965-2011-00578
    Event Type
    Injury
    Date Received
    August 25, 2011
    Date of Event
    June 8, 2011
    Report Date
    July 28, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    JDW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RETURNED.

    Description of Event or Problem · 1

    A DEVICE REPORT RECEIVED FROM (B)(6) INDICATED A HOSPITAL IN (B)(6) REPORTED: PT WAS IMPLANTED WITH PFNA BLADE AND NAIL ON (B)(6)-2011 AND WAS DISCHARGED FROM THE HOSPITAL ON (B)(6)-2011. DURING SURGEON FOLLOW UP VISIT ON (B)(6)-2011 SURGEON DISCOVERED THAT THE BLADE COULD NOT BE TELESCOPED NORMALLY AND PRESENTED A RISK TO CUT OUT. THE BLADE DID PENETRATE THE FEMORAL HEAD DATE UNK. SURGEON REMOVED THE HARDWARE AND REVISED PT WITH ARTIFICIAL FEMORAL JOINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFNA-II 012XS 130 DEGREES L170 TAN :PFNA-II 012XS 130 DEGREES JDW SYNTHES GMBH 2651555

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male PFNA BLADE.| PFNA BLADE