BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRILOGY SPIKED SHELL

    MDR report key: 2950041 · Received February 6, 2013

    Report

    Report Number
    2648920-2013-00040
    Event Type
    Injury
    Date Received
    February 6, 2013
    Date of Event
    January 2, 2013
    Report Date
    January 7, 2013
    Manufacturer
    ZIMMER
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVAL SUMMARY: NO DEVICES OR PHOTOS WERE RETURNED, THEREFORE THE CONDITIONS OF THE COMPONENTS IS UNK. NEITHER X-RAYS NOR SURGICAL NOTES ARE PROVIDED FOR REVIEW; IT IS UNK IF THE DEVICES WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. PT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS ARE AGE, BONE QUALITY, HEIGHT/WEIGHT, ACTIVITY LEVEL ,TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT), AND RELEVANT MEDICAL HISTORY. REHABILITATION PROTOCOL AND ADHERENCE THERETO IS UNK. WITH THE INFO PROVIDED, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. CAUSE CANNOT BE DEFINITIVELY DETERMINED. EVAL CODES: 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS EXPERIENCING PAIN EIGHT MONTHS AFTER THE INITIAL SURGERY. DURING THE REVISION OPERATION, IT WAS DETERMINED THAT THE SHELL WAS LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50088 TRILOGY SPIKED SHELL LPH ZIMMER 61817455

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention