BEUDAMED
    FDA Adverse Event Other Summary report: N

    FITMORE HIP STEM B EXT. OFFS. SIZE 7

    MDR report key: 3202124 · Received June 18, 2013

    Report

    Report Number
    9613350-2013-01649
    Event Type
    Other
    Date Received
    June 18, 2013
    Date of Event
    December 7, 2011
    Report Date
    June 14, 2013
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR DID NOT RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW, AS THE PT HAS NOT BEEN REVISED TO DATE. THE CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED, AS THE PT HAS NOT BEEN REVISED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, AN UPDATED REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS ABOUT A BILATERAL PT WITH 2 FITMORE HIP STEMS IMPLANTED IN (B)(6) 2009, LEFT SIDE AND IN (B)(6) 2009, RIGHT SIDE. THIS COMPLAINT ONLY INVOLVES THE LEFT HIP: IT WAS REPORTED THAT AT 2-YEAR FOLLOW-UP CHECK, AFTER REHAB, THE PT COMPLAINED OF FEMORAL PAIN. THE PT WAS EXPERIENCING SEVERE PAIN IN THE ANTERIOR LEFT THIGH AFTER WALKING AND GROIN PAIN AT REST ON THE RIGHT SIDE. AS PER SURGEON'S COMMENT, "IT IS MOST LIKELY DUE TO OVERLOADING." IT IS ALSO REPORTED THAT BOTH KNEES AND LUMBAR SPINE OF THE PT IS BEING AFFECTED POSSIBLY DUE TO PT'S WEIGHT AND THE PT HAS HAD A TENDENCY OF FALLING. AS TREATMENT FOR PAINS, THE PT HAS BEEN GIVEN PAIN MEDICATION (NAME OF DRUG NOT PROVIDED). THERE IS NO REPORT OF PLANNED REVISION SURGERY AS PAIN IS TOLERATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    275395 FITMORE HIP STEM B EXT. OFFS. SIZE 7 ZIMMER POROLOCK MIS STEM KWA ZIMMER GMBH 2493140

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other