BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION HIP INSTRUMENT

    MDR report key: 1923227 · Received November 12, 2010

    Report

    Report Number
    9614497-2010-00001
    Event Type
    Other
    Date Received
    November 12, 2010
    Date of Event
    October 27, 2010
    Report Date
    November 12, 2010
    Manufacturer
    GREATBATCH MEDICAL, INC.
    Product Code
    LXH
    PMA / PMN Number
    87-H-TO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. FURTHER REPORTS WILL FOLLOW AFTER INVESTIGATION OF THE DEFECTIVE PARTS. ADD'L INFO FROM THE VOLUNTARY REPORT: (B)(4): ALSO REPORTED TO: MANUFACTURER. "THE REPORTER WANT THEIR IDENTITY DISCLOSED."

    Description of Event or Problem · 1

    AFTER POST-OP, DOCTOR REC'D CALL FROM RADIOLOGIST AND INDICATED THAT THERE WAS A PIECE OF AN INSTRUMENT IN PT. PART # 803-00-132, LOT # 37563L25 ... LOCKING CLIPS MUST HAVE SHEARED OFF AND WERE LEFT IN PT. THE PIECES OF THE CALCAR REAMER BLADE WERE LEFT IN THE PT. "ADD'L INFO FROM THE VOLUNTARY REPORT": INSTRUMENT FAILURE - AFTER POST-OP, THE DOCTOR REC'D A CALL FROM THE RADIOLOGIST WHO INDICATED THERE WAS A PIECE OF AN INSTRUMENT IN THE PT. THE LOCKING CLIPS MUST HAVE SHEARED OFF AND WERE LEFT IN THE PT. IN THIS REPORT, ANY ASSOCIATED INSTRUMENTS/PARTS WILL BE FORWARDED TO (B)(4) FOR FURTHER INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOUNDATION HIP INSTRUMENT FEMORAL CALCAR BLADE INSTRUMENT LXH GREATBATCH MEDICAL, INC. T11818 37564L25

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other