BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINECTIV TECHNOLOGY MODULAR NECK

    MDR report key: 2162032 · Received July 12, 2011

    Report

    Report Number
    1822565-2011-01620
    Event Type
    Injury
    Date Received
    July 12, 2011
    Date of Event
    June 3, 2011
    Report Date
    June 13, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS REC'D FROM A HEALTH PROFESSIONAL WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVAL SUMMARY: SURGICAL NOTES WERE PROVIDED FROM A SURGERY WHERE A +8MM EXTENDED OFFSET NECK WAS IMPLANTED. IT WAS DESCRIBED THAT THE LEG LENGTH AND OFFSET WERE CLINICALLY EQUALIZED. SURGICAL NOTES WERE PROVIDED FROM A REVISION ON (B)(6) 2011 WHICH WAS CARRIED OUT DUE TO EXCESSIVE OFFSET. AFTER EXPOSURE, PRIOR TO REVISING THE NECK, THE LEG WAS TAKEN THROUGH A TRAIL RANGE OF MOTION AND WAS STABLE. COMPONENTS WERE ALSO DESCRIBED AS WELL POSITIONED. NO COMPLICATIONS WERE NOTED. X-RAYS WERE NOT PROVIDED; IT IS UNK WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFO PROVIDED. EVAL: THE MFG RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING INDICATING THAT THE MODULAR NECK WAS MANUFACTURED, INSPECTED, AND PACKAGED TO SPECIFICATION. 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 ACTON IS NOT INDICATED. SHOULD ADD'L SUBSTANTIVE INFO BE REC'D, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT WAS REVISED DUE TO EXCESSIVE OFFSET OF THE NECK MODULE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KINECTIV TECHNOLOGY MODULAR NECK LPH ZIMMER, INC. 60870826

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention