BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER M/L TAPER MODULAR FEMORAL STEM

    MDR report key: 2010527 · Received March 1, 2011

    Report

    Report Number
    1822565-2011-00453
    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 Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE SURGICAL NOTES DESCRIBED AN UNEVENTFUL PRIMARY SURGERY WITH POSITIVE ASSESSMENTS MADE IN REGARD TO LEG LENGTH, CUP POSITION AND ROM. PAIN CAN BE CAUSED FOR A VARIETY OF REASONS SOME OF WHICH ARE GIVEN HERE: DISLOCATION OF THE JOINT, INFECTION, SOFT TISSUE IMPINGEMENT OF THE PROSTHESIS, PSEUDO TUMORS DUE TO PARTICULATE DEBRIS, LEG LENGTH / OFFSET DISCREPANCY, LOOSENING OF THE PROSTHESIS, FRACTURE / BREAKAGE OF THE PROSTHESIS. WITH THE INFO CURRENTLY PROVIDED, NO CAUSE FOR PAIN IN THIS PT CAN BE FOUND. FURTHER, NO DESIGN DEFICIENCY CAN BE IDENTIFIED. 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 ADD'L SUBSTANTIVE INFO BE REC'D, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT IS EXPERIENCING PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER M/L TAPER MODULAR FEMORAL STEM LPH ZIMMER INC 60862141

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other KINECTIV TECHNOLOGY MODULAR NECK| CATALOG #00784800200, LOT #60892503