BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRILOGY SHELL WITH CLUSTER HOLES

    MDR report key: 4092081 · Received August 21, 2014

    Report

    Report Number
    1822565-2014-01020
    Event Type
    Injury
    Date Received
    August 21, 2014
    Report Date
    July 22, 2014
    Manufacturer
    ZIMMER, INC.
    Product Code
    MEH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: COMPATIBILITY OF THE IMPLANTED DEVICES TOGETHER WAS CONFIRMED. NEITHER OPERATIVE NOTES NOR X-RAYS HAVE BEEN PROVIDED. COMPONENT FIT AND ORIENTATION PER THE SURGICAL TECHNIQUE ARE UNK. IN GENERAL, PT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS INCLUDE: 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. NO ADD'L COMPLAINTS OF PAIN HAVE BEEN RECEIVED. ROOT CAUSE CANNOT BE DETERMINED WITH THE INFO PROVIDED. EVAL CODES: IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT IS EXPERIENCING PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504675 TRILOGY SHELL WITH CLUSTER HOLES MEH ZIMMER, INC. 61813377

    Patients

    Seq Age Sex Outcome Treatment
    1 LOT 61542748| LOT 61796237, MFG BY ZIMMER B.V.PONCE, PR| TRILOGY LONGEVITY POLY LINER:CATALOG 00630505036,| LOT 60810236| KINECTIV MODULAR NECK: CATALOG 00784801100,| VERSYS FEMORAL HEAD: CATALOG 00801803602,| LOT 61847065, MFG BY ZIMMER B.V.PONCE, PR| ZIMMER M/L TAPER FEMORAL STEM: CATALOG 65771300900