BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER M/L TAPER KINECTIVE FEMORAL STEM

    MDR report key: 2603043 · Received June 5, 2012

    Report

    Report Number
    1822565-2012-01205
    Event Type
    Injury
    Date Received
    June 5, 2012
    Date of Event
    May 5, 2009
    Report Date
    May 8, 2012
    Manufacturer
    ZIMMER INC
    Product Code
    LWJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRIMARY SURGICAL NOTES HAD BEEN PROVIDED AND STATED THAT THE FINAL REDUCTION HAD EXCELLENT RANGE OF MOTION AND STABILITY. NO COMPLICATIONS HAD BEEN NOTED. REVISION OP NOTES STATED THAT THE FEMORAL COMPONENT HAD SUBSIDED SIGNIFICANTLY RESULTING IN A 15 TO 20 MM LIMB LENGTH INEQUALITY. X-RAYS WERE NOT PROVIDED; IT IS UNKNOWN WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. PATIENT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS BONE QUALITY, HEIGHT/WEIGHT, ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT), AND RELEVANT MEDICAL HISTORY ARE UNKNOWN. ADHERENCE TO REHABILITATION PROTOCOL IS UNKNOWN. A DEFINITIVE CAUSE FOR THE EXPERIENCE OBSERVED CANNOT BE DETERMINED WITH CERTAINTY. 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 PATIENT WAS REVISED DUE TO STEM SUBSIDENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER M/L TAPER KINECTIVE FEMORAL STEM LWJ ZIMMER INC 60806863

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention