BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZMR HIP SYSTEM OTJ METAL PROVISIONAL BODY

    MDR report key: 1654854 · Received April 6, 2010

    Report

    Report Number
    1822565-2010-00202
    Event Type
    Malfunction
    Date Received
    April 6, 2010
    Date of Event
    February 24, 2010
    Report Date
    February 25, 2010
    Manufacturer
    ZIMMER INC.
    Product Code
    LXH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE PER STATES THAT THE SURGEON "TAPPED" THE TRIAL ONTO THE STEM. THIS AGREES WITH THE PROCEDURE DESCRIBED IN THE SURGICAL TECHNIQUE. IT IS MOST LIKELY THAT THE SURGEON OVERESTIMATED THE STRENGTH OF THE "TAP" NEEDED TO TEMPORARILY FIX THE PROVISIONAL BODY ONTO THE STEM. THE SURGEON APPEARS TO HAVE FOLLOWED THE METHOD SUGGESTED BY THE SURGICAL TECHNIQUE TO FREE THE STUCK ASSEMBLY AND RESOLVE ISSUE. EVALUATION: AS RETURNED THE STEM IS SEIZED WITH IN THE PROXIMAL TRIAL. CORROSION IS NOTED AT THE JUNCTION BETWEEN THE TRIAL AND THE STEM. IT IS NOT KNOWN, HOWEVER, WHEN THIS CORROSION WAS FIRST EVIDENT. DEVICE HISTORY RECORDS FOR BOTH THE STEM AND THE PROXIMAL TRIAL WERE REVIEWED AND NO ANOMALIES WERE NOTED. THE TRIAL HAD A POTENTIAL FIELD AGE OF APPROX 15 MONTHS AT THE TIME OF THE INCIDENT. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT IS REPORTED THAT AFTER INSERTING THE DISTAL PORTION OF THE STEM, THE SURGEON WAS TRIALING WITH THE METAL (B)(4) TRIALS. HE TAPPED THE TRIAL ON THE STEM. AFTER HE TRIALED THE BODY, HE WANTED TO CHANGE THE VERSION. HOWEVER, HE COULD NOT LOOSEN THE JACK SCREW. THE METAL BODY TRIAL WOULD NOT RELEASE FROM THE TAPER. IT WAS UNABLE TO BE REMOVED ON THE BACK TABLE EITHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZMR HIP SYSTEM OTJ METAL PROVISIONAL BODY HIP INSTRUMENT LXH ZIMMER INC. NA 61134818

    Patients

    Seq Age Sex Outcome Treatment
    1 Other