BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER M/L TAPER FEMORAL STEM PRESS-FIT

    MDR report key: 2010520 · Received March 1, 2011

    Report

    Report Number
    1822565-2011-00449
    Event Type
    Injury
    Date Received
    March 1, 2011
    Report Date
    February 1, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: X-RAYS, PATIENT'S PAST MEDICAL HISTORY, AND PATIENT'S ACTIVITY LEVEL WERE NOT PROVIDED. SURGICAL NOTES HAVE BEEN PROVIDED AND DO NOT INDICATE ANY COMPLICATION. GIVEN THE INFORMATION PROVIDED, A DEFINITIVE CAUSE FOR THE EXPERIENCE REPORTED 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 IS PRESENTING WITH PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER M/L TAPER FEMORAL STEM PRESS-FIT LPH ZIMMER, INC. 60761939

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other