BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLUSTER-HOLE POROUS SHELL

    MDR report key: 2030612 · Received March 18, 2011

    Report

    Report Number
    1822565-2011-00681
    Event Type
    Injury
    Date Received
    March 18, 2011
    Report Date
    October 28, 2009
    Manufacturer
    ZIMMER, INC.
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: NO PRODUCT WAS RETURNED FOR EVAL. ALSO, NO X-RAYS OR OPERATIVE NOTES WERE RETURNED FOR REVIEW. PT INFO SUCH AS HEIGHT, WEIGHT, AND ACTIVITY LEVEL IS UNK. BASED ON THE AVAILABLE INFO, A DEFINITIVE ROOT CAUSE CANNOT BE ASCERTAINED AT THIS TIME. EVAL: REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECS. 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 RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED. THIS MDR WAS IDENTIFIED DURING AN INTERNAL REVIEW TO MEET REPORTING REQUIREMENTS AND THEREFORE, IS BEING FILED LATE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT HAS PAIN AND DECREASED MOBILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLUSTER-HOLE POROUS SHELL HIP PROSTHESIS JDI ZIMMER, INC. 1594968

    Patients

    Seq Age Sex Outcome Treatment
    1 Other EPSILON ACETABULAR SYSTEM DURASUL HOODED INSERT:| CATALOG #741901120, LOT #60427688| TOTAL HEAD, -4.0 MM NECK: CATALOG #721032004,| BONE SCREW, CATALOG #430107025, LOT # UNK| LOT #60444211| CATALOG #437732049, LOT #60296833| APR HIP SYSTEM POROUS DISTALLY TEXTURED TAPER: