BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRILOGY LONGEVITY CROSSLINKED POLY LINER

    MDR report key: 2103626 · Received May 16, 2011

    Report

    Report Number
    1822565-2011-01186
    Event Type
    Injury
    Date Received
    May 16, 2011
    Date of Event
    April 11, 2011
    Report Date
    April 19, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: NO DEVICES OR PHOTOS WERE REC'D; THEREFORE, THE CONDITION OF THE COMPONENTS IS UNK. SURGICAL NOTES AND X-RAYS WERE NOT PROVIDED; IT IS UNK WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. DISLOCATION MAY BE ASSOCIATED WITH A NUMBER OF MECHANISMS: UNSATISFACTORY PLACEMENT OF THE COMPONENT PARTS, EXTENT OF COMPONENT STABILITY, EXTENT OF SOFT TISSUE TENSION, INADEQUATE SOFT TISSUE TENSION, POOR FUNCTIONAL MUSCLES, AND/OR PT BEHAVIOR. THERE IS INSUFFICIENT INFORMATION TO DETERMINE THE ROOT CAUSE OF THIS EVENT. 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 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 THE PT WAS REVISED FOR CHRONIC HIP DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRILOGY LONGEVITY CROSSLINKED POLY LINER LPH ZIMMER, INC. 61121937

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention HEAD, LOT #61138034, MANUFACTURED AT ZIMMER BV| (B)(4)| CATALOG #00801803202, VERSYS HIP SYSTEM FEMORAL