BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRILOGY ACETABULAR SHELL WITH CLUSTER HOLES

    MDR report key: 4112601 · Received September 10, 2014

    Report

    Report Number
    2648920-2014-00240
    Event Type
    Injury
    Date Received
    September 10, 2014
    Date of Event
    October 17, 2011
    Report Date
    August 11, 2014
    Manufacturer
    ZIMMER
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: 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. PATIENT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS AGE, BONE QUALITY, HEIGHT/WEIGHT, ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT), AND RELEVANT MEDICAL HISTORY. ADHERENCE TO REHABILITATION PROTOCOL IS UNK. CAUSE CANNOT BE DEFINITIVELY DETERMINED. 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 AVAILABLE INFO, 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.

    Description of Event or Problem · 1

    IT IS REPORTED THE PATIENT WAS REVISED DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559790 TRILOGY ACETABULAR SHELL WITH CLUSTER HOLES LPH LPH ZIMMER 61548327

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CATALOG #00801803602| VERSYS HIP SYSTEM FEMORAL STEM: LOT #61475416| MANUFACTURED BY ZIMMER INC. (B)(4)| CATALOG #00784101200| VERSYS FEMORAL HEAD: LOT #61833390| MANUFACTURED BY ZIMMER INC. (B)(4)