BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRILOGY CROSSLINKED POLYETHYLENE LINER

    MDR report key: 2220288 · Received August 16, 2011

    Report

    Report Number
    2648920-2011-00045
    Event Type
    Injury
    Date Received
    August 16, 2011
    Date of Event
    March 24, 2010
    Report Date
    July 18, 2011
    Manufacturer
    ZIMMER
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: SURGICAL NOTES WERE PROVIDED FROM THE PRIMARY SURGERY ON (B)(4) 2010 AND REVISION SURGERY ON (B)(4) 2010. NO COMPLICATIONS WERE NOTED IN THE PRIMARY NOTES. IT WAS NOTED IN THE REVISION NOTES THAT THE PATIENT HAD RECURRENT DISLOCATIONS WHICH WERE REDUCED WITH CLOSED REDUCTION. IT WAS NOTED IN THE REVISION NOTES THAT THERE WAS IMPINGEMENT BETWEEN THE NECK OF THE STEM AND THE ACETABULAR LINER. THIS MAY HAVE BEEN A SOURCE OF THE INSTABILITY AND DISLOCATIONS. X-RAYS WERE NOT PROVIDED; IT IS UNKNOWN WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. TAKING THE ABOVE INFORMATION INTO CONSIDERATION, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. EVALUATION: 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 RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, (B)(4) CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT WAS REVISED DUE TO INSTABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRILOGY CROSSLINKED POLYETHYLENE LINER LPH ZIMMER 61236576

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention