BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LONGEVITY HIGHLY CROSSLINKED LINER

    MDR report key: 2130573 · Received June 14, 2011

    Report

    Report Number
    1822565-2011-01379
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    April 1, 2011
    Report Date
    May 18, 2011
    Manufacturer
    ZIMMER INC.
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED FROM A HEALTH PROFESSIONAL WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVAL SUMMARY: OP NOTES OF THE DAY THESE COMPONENTS WERE IMPLANTED WAS PROVIDED, BUT DID NOT INDICATE ANY COMPLICATIONS. X-RAYS WERE NOT PROVIDED; IT IS UNK WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. PT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS INCLUDE (BUT NOT LIMITED TO): AGE, BONE QUALITY, HEIGHT/WEIGHT, ACTIVITY LEVEL, AND TYPE OF ACTIVITY (LOW IMPACT VS HIGH IMPACT). THERE IS INSUFFICIENT INFO TO PERFORM A PROBABLE CAUSE ANALYSIS. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFO PROVIDED. EVAL: THE MFG RECORDS OF THESE COMPONENTS HAVE BEEN REVIEWED AND FOUND TO BE CONFORMING INDICATING THAT THE DEVICES WERE MANUFACTURED, INSPECTED, AND PACKAGED TO SPECIFICATION.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT DISLOCATED AND IS PENDING REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LONGEVITY HIGHLY CROSSLINKED LINER JDI ZIMMER INC. 61548809

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other LOT #61559680| CATALOG #00875706001, LOT #61361001| (B)(4)| KINECTIV MONDULAR NECK, CATALOG #00784802301,| LOT #61496209, (B)(4)| VERSYS HIP FEMORAL HEAD, CATALOG #00801804002,| TRABECULARMETAL SHELL WITH CLUSTER HOLES,