BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER M/L TAPER MODULAR FEMORAL STEM

    MDR report key: 2546601 · Received April 20, 2012

    Report

    Report Number
    1822565-2012-00881
    Event Type
    Injury
    Date Received
    April 20, 2012
    Date of Event
    March 20, 2012
    Report Date
    March 23, 2012
    Manufacturer
    ZIMMER INC
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: IT IS REPORTED THAT THE PT EXPERIENCED A MEDIAL FRACTURE OF THE PROXIMAL FEMUR AND WAS REVISED. 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. IN GENERAL, PT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS INCLUDE: AGE, BONE QUALITY, HEIGHT/WEIGHT, ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT), AND RELEVANT MEDICAL HISTORY. ADHERENCE TO REHABILITATION PROTOCOL IS UNK. A DEFINITIVE CONCLUSION CANNOT BE REACHED WITH THE INFO PROVIDED. 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 INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THEY EXPERIENCED A "POPPING" SOUND. X-RAYS REVEALED A MEDIAL FRACTURE OF THE PROXIMAL FEMUR. THE PT WAS REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER M/L TAPER MODULAR FEMORAL STEM KWA ZIMMER INC 61796983

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention