BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LPS FEMORAL COMPONENT POROUS

    MDR report key: 2051092 · Received April 5, 2011

    Report

    Report Number
    1822565-2011-00858
    Event Type
    Injury
    Date Received
    April 5, 2011
    Report Date
    March 7, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: NEITHER X-RAYS NOR OPERATIVE NOTES WERE PROVIDED. AS SUCH, THE SURGICAL TECHNIQUE CANNOT BE REVIEWED AND THE IMPLANT CONSTRUCT CANNOT BE ANALYZED RADIOGRAPHICALLY. PT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS AGE, BONE QUALITY, HEIGHT/WEIGHT, ACTIVITY LEVEL, AND TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT) ARE UNK. BASED ON THE AVAILABLE INFO, AN EXACT CAUSE FOR THE REPORTED CONDITION CANNOT BE DETERMINED. MFG DOCUMENTATION FOR THE REPORTED DEVICE WAS REVIEWED AND INDICATES IT WAS 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 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 IS PRESENTING WITH PAIN. A REVISION SURGERY IS PLANNED FOR (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN LPS FEMORAL COMPONENT POROUS JWH ZIMMER, INC. 60084424

    Patients

    Seq Age Sex Outcome Treatment
    1 Other