BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER M/L TAPER MODULAR FEMORAL STEM

    MDR report key: 2120096 · Received June 7, 2011

    Report

    Report Number
    1822565-2011-01312
    Event Type
    Injury
    Date Received
    June 7, 2011
    Date of Event
    December 22, 2010
    Report Date
    May 9, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE DEVICES WERE NOT AVAILABLE FOR ANALYSIS BECAUSE THEY WERE IMPLANTED. THE INSTRUMENTS AND TECHNIQUE USED IS NOT KNOWN. SURGICAL NOTES WERE NOT PROVIDED. X-RAYS WERE NOT PROVIDED. PT BONE QUALITY IS UNK. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. EVALUATION: THE MANUFACTURING RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING INDICATING THAT THE DEVICES WERE MANUFACTURED, INSPECTED, AND PACKAGED TO SPECIFICATION. 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 REC'D, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT A FEMUR FRACTURE OCCURRED DURING IMPLANTATION OF THE STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER M/L TAPER MODULAR FEMORAL STEM LPH ZIMMER, INC. 61498035

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention