BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN LCCK ARTICULAR SURFACE

    MDR report key: 2109900 · Received May 10, 2011

    Report

    Report Number
    1822565-2011-01130
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    April 7, 2011
    Report Date
    April 11, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVALUATION SUMMARY: PER THE (B)(4), THE TIBIA IS TO BE AFFIXED TO THE STEM EXTENSION WITH EITHER THE 3.5MM HEX-HEAD SCREW PACKAGED WITH THE STEM EXTENSION OR THE LOCKING SCREW PACKAGED WITH THE ARTICULAR SURFACE. THIS STEP IS TO OCCUR PRIOR TO IMPLANTATION. BASED ON THE RECEIVED REPORT, NEITHER OF THESE METHODS OF FIXATION WAS USED PRIOR TO ATTEMPTED IMPLANTATION. IT IS LIKELY THAT THIS DEVIATION FROM THE SURGICAL TECHNIQUE IS WHAT LED TO THE REPORTED DISSOCIATION, BUT WITHOUT FURTHER INFORMATION THIS CANNOT BE DETERMINED CONCLUSIVELY. EVALUATION: REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE THREADS OF THE SCREW WOULD NOT ENGAGE WITH THE STEM EXTENSION. THE SCREW WAS EVALUATED AND NO IMPERFECTIONS OR DEFECTS WERE OBSERVED. AFTER SEVERAL ATTEMPTS, THE SURGEON DECIDED TO CLOSE THE PATIENT WITHOUT THE USE OF THE LOCKDOWN SCREW. POST OP X-RAYS INDICATE THAT THE STEM EXTENSION HAD BECOME DISSOCIATED FROM THE TIBIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN LCCK ARTICULAR SURFACE JWH ZIMMER, INC. 61638068

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR NEXGEN COMPLETE KNEE SOLUTION STEM EXTENSION| STRAIGHT: CATALOG # 00598801014, LOT #61522074