BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN COMPLETE KNEE SOLUTION CRUCIATE RETAINING (CR) PROVISIONAL-ARTICULAR SURF

    MDR report key: 1162214 · Received September 3, 2008

    Report

    Report Number
    1822565-2008-00575
    Event Type
    Malfunction
    Date Received
    September 3, 2008
    Date of Event
    July 17, 2008
    Report Date
    July 17, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: IT IS REPORTED THAT THE DEVICE BROKE WHEN IT WAS HIT BY A MALLET. IT IS LIKELY THAT THE DEVICE EXPERIENCED HIGH IMPACT LOAD WHICH CAUSED THE FRACTURE OF THE DEVICE. IMPROPER USE APPEARS TO BE THE CAUSE OF THE PROBLEM. AS RETURNED, THE PROVISIONAL IS FRACTURED INTO THREE PIECES. ADDITIONALLY, THE SPECIMEN SHOWS EXTENSIVE WEAR IN THE FORM OF NICKS, SCRATCHES, AND GOUGES. THE UNDERSIDE ALSO SHOWS FRACTURE DAMAGE TO THE OUTER LIP ON THE POSTERIOR SIDE. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. THERE IS NO INDICATION THAT DESIGN OR MANUFACTURE CONTRIBUTED TO THIS OUTCOME. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE DEVICE WAS BROKEN DUE TO A BLOW FROM THE MALLET DURING INSERTION. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN COMPLETE KNEE SOLUTION CRUCIATE RETAINING (CR) PROVISIONAL-ARTICULAR SURF KNEE INSTRUMENT JWH ZIMMER, INC. NA 73014000

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK