BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTINUUM TM SHELL WITH CLUSTER HOLES

    MDR report key: 2875121 · Received December 12, 2012

    Report

    Report Number
    1822565-2012-02514
    Event Type
    Injury
    Date Received
    December 12, 2012
    Date of Event
    November 7, 2012
    Report Date
    November 13, 2012
    Manufacturer
    ZIMMER, INC.
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: REVISION NOTES STATE THAT THE PATIENT STARTED EXPERIENCING THE ILIOPSOAS TENDON DISCOMFORT AND PAIN FOUR WEEKS FOLLOWING THE PRIOR SURGERY, AND X-RAYS REVEALED A MINOR LEG LENGTH DISCREPANCY, AS WELL AS A LATERALIZED LEFT ACETABULAR COMPONENT. IT WAS ALSO NOTED THAT THE TENDON IMPINGEMENT WAS DUE TO LATERAL CUP POSITION AND MINOR LEG LENGTHENING. TRAILING OF COMPONENTS AT THE REVISION NOTED NO IMPINGEMENT WITH THE PSOAS TENDON. CAUSE CANNOT BE DEFINITIVELY DETERMINED. 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.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT WAS REVISED DUE TO ILIOPSOAS TENDONITIS AND IMPINGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTINUUM TM SHELL WITH CLUSTER HOLES LZO ZIMMER, INC. 62087843

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention CATLOG #00885101340, LOT #62035648| VERSYS FEMORAL HEAD: CATALOG #00801804002,| LOT # 62146112, MFG BY ZIMMER (B)(4)| CONTINUUM VIVACIT-E NEUTRAL LINER: