BEUDAMED
    FDA Adverse Event Other Summary report: N

    HUMERAL STEM, 6MM

    MDR report key: 1353137 · Received March 30, 2009

    Report

    Report Number
    1220246-2009-00033
    Event Type
    Other
    Date Received
    March 30, 2009
    Date of Event
    March 4, 2009
    Report Date
    March 4, 2009
    Manufacturer
    ARTHREX, INC.
    Product Code
    KWS
    PMA / PMN Number
    K010124
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS REQUESTED FOR EVAL, BUT WAS NOT RETURNED BECAUSE IT WAS REPORTED AS GIVEN TO THE PT, THEREFORE THE COMPLAINANT'S EVENT COULD NOT BE VERIFIED. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFO AVAILABLE AND WITHOUT DEVICE EVAL. CONFIRMATION OF THE DEVICE SIZE ALONG WITH LOT NUMBER WAS REQUESTED, BUT NOT PROVIDED, THEREFORE DEVICE HISTORY RECORD REVIEW COULD NOT BE CONDUCTED. BASED ON THE INFO PROVIDED, THE MOST LIKELY REASON FOR THIS TYPE OF EVENT IS NOT TIGHTENING THE LOCKING SCREW WITH THE CORRECT TORQUE OR NOT SEATING THE DRIVER INTO THE LOCKING SCREW CORRECTLY. PER THE PRODUCT DFU, A WARNING IS PROVIDED WHICH STATES FAILURE TO ACHIEVE THE APPROPRIATE TORQUE REQUIREMENTS WHEN TIGHTENING LOCKING SCREWS MAY RESULT IN THE PREMATURE LOOSENING OF THE DEVICE. THE POTENTIAL CAUSES OF THIS EVENT ARE BEING COMMUNICATED TO THE EVENT REPORTER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SHOULDER REVISION OCCURRED FOR A DEVICE THAT WAS ORIGINALLY IMPLANTED BY ANOTHER SURGEON AS A HEMI-SHOULDER ON (B)(6) 2002. THE REPORTER/SURGEON REVISED THE PT FROM A HEMI TO A TOTAL SHOULDER. POST-OP F/U WITH THE COMPANY REP PROVIDED INFO THAT THE REVISION WAS AN OPEN CASE THAT REVEALED THE TRUNNION HAD LOOSENED FROM THE STEM. THE REVISION WAS COMPLETED SUCCESSFULLY AND THE PT'S CURRENT CONDITION WAS REPORTED AS FINE. NO FURTHER PT INFO WAS PROVIDED AT THE TIME OF THIS REPORT OR MADE AVAILABLE IN RESPONSE TO F/U COMMUNICATION. NO ADD'L ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUMERAL STEM, 6MM KWS ARTHREX, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention INFO REQUESTED, BUT NOT PROVIDED.