BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRILOGY ACETABULAR SHELL

    MDR report key: 2033478 · Received March 24, 2011

    Report

    Report Number
    1822565-2011-00739
    Event Type
    Injury
    Date Received
    March 24, 2011
    Report Date
    August 27, 2009
    Manufacturer
    ZIMMER
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICES OR PHOTOS WERE RECEIVED; THEREFORE, THE CONDITION OF THE COMPONENTS IS UNK. SURGICAL NOTES WERE NOT PROVIDED. 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 SUCH AS BONE QUALITY, HEIGHT/WEIGHT, ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT) ARE UNK. THERE IS INSUFFICIENT INFO TO PERFORM A PROBABLE CAUSE ANALYSIS. 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 INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC CONSIDERS THE INVESTIGATION CLOSED. THIS MDR WAS IDENTIFIED DURING AN INTERNAL REVIEW TO MEET REPORTING REQUIREMENTS AND THEREFORE IS BEING FILED LATE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT HAS PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRILOGY ACETABULAR SHELL LPH ZIMMER 60513623

    Patients

    Seq Age Sex Outcome Treatment
    1 Other CATALOG # 00630505032, LOT # 60487469| VERSYS HIP FEMORAL HEAD, CATALOG # 00801803201,| TRABECULAR METAL FEMORAL STEM,| CATALOG # 00786401220, LOT # 60474182,| LOT # 60520422| TRILOGY ACETABULAR LONGEVITY LINER,| MANUFACTURED AT ZIMMER INC, (B)(4)