BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER M/L TAPER FEMORAL STEM

    MDR report key: 2063713 · Received April 13, 2011

    Report

    Report Number
    1822565-2011-00939
    Event Type
    Injury
    Date Received
    April 13, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 17, 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

    EVAL SUMMARY: X-RAYS WERE NOT PROVIDED; IT IS UNK WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. SURGICAL NOTES WERE PROVIDED FROM THE PRIMARY SURGERY AND STATED THAT THE FEMORAL COMPONENT HAD "EXCELLENT IMMEDIATE PRESS-FIT STABILITY". IN THE REVISION SURGICAL NOTES, THE FEMORAL STEM WAS DESCRIBED AS LOOSE AND COULD BE REMOVED WITH A SLAP HAMMER AFTER THE SHOULDER OF THE PROSTHESIS WAS DEBRIDED. DETAILS REGARDING THE SURROUNDING BONE QUALITY WERE NOT DESCRIBED. PT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS BONE QUALITY, ACTIVITY LEVEL, AND TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT) WERE NOT PROVIDED. ADHERENCE TO REHABILITATION PROTOCOL IS UNK. A ROOT CAUSE CANNOT BE DETERMINED WITH THE INFO PROVIDED. EVAL: 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 FOR LOOSENING OF THE FEMORAL IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER M/L TAPER FEMORAL STEM LPH ZIMMER INC 60976032

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention