BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTIPOLAR BIPOLAR SHELL

    MDR report key: 2921504 · Received January 10, 2013

    Report

    Report Number
    2648920-2013-00030
    Event Type
    Injury
    Date Received
    January 10, 2013
    Date of Event
    December 14, 2012
    Report Date
    December 14, 2012
    Manufacturer
    ZIMMER
    Product Code
    KWY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVAL SUMMARY: SURGICAL NOTES WERE NOT PROVIDED. X-RAYS WERE NOT PROVIDED; IT IS UNK WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. PT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS AGE, BONE QUALITY, HEIGHT/WEIGHT, ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS HIGH IMPACT), AND RELEVANT MEDICAL HISTORY ARE UNK. ADHERENCE TO REHABILITATION PROTOCOL IS UNK. CAUSE CANNOT BE DEFINITIVELY DETERMINED. 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 INFO BE RECEIVED, 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 TO A TOTAL HIP FOR AN UNK REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13667 MULTIPOLAR BIPOLAR SHELL KWY ZIMMER 60452907

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention ZIMMER TAPER FEMORAL HEAD: CAT#00902603000,| LOT#60423132| LOT#60549973| MULTIPOLAR BIPOLAR LINER: CAT#00500106028,