BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MUILTIPOLAR BIPOLAR CUP

    MDR report key: 4171073 · Received July 15, 2014

    Report

    Report Number
    2648920-2014-00175
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Date of Event
    June 12, 2014
    Report Date
    June 16, 2014
    Manufacturer
    ZIMMER
    Product Code
    KWY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE SURGICAL TECHNIQUE NOTES TO CHECK THE CONDITION OF THE LOCKING RING PRIOR TO IMPLANTATION, AND STATES, "PRIOR TO PLACING THE METAL SHELL OVER THE POLYETHYLENE LINER, ENSURE THAT THE METAL RETAINING RING FREELY ROTATES BY MOVING THE METAL TABS." NO ADD'L COMPLAINTS HAVE BEEN RECEIVED AGAINST THIS LOT OF BIPOLAR SHELLS. WITH THE INFO PROVIDED, IT IS LIKELY THAT THE SURGICAL TECHNIQUE WAS NOT FOLLOWED AND THE LOCKING RING WAS NOT INSPECTED PRIOR TO LINER ASSEMBLY. EVAL CODES: THE SHELL WAS RETURNED FOR REVIEW WITH THE LOCKING RING STUCK IN THE LOCKING RING GROOVE. THE RING WAS DISASSEMBLED FOR INSPECTION AND MET PRINT SPECS WHERE MEASURED. THE SHELL WAS MEASURED AND MET SPECS WHERE MEASURED, INCLUDING A GO-GAUGE FOR THE LOCKING RING GROOVE WIDTH.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE LOCKING MECHANISM WAS JAMMED AND WOULD NOT ALLOW THE LINER TO BE INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413541 MUILTIPOLAR BIPOLAR CUP KWY ZIMMER 62618919

    Patients

    Seq Age Sex Outcome Treatment
    1