BEUDAMED
    FDA Adverse Event Other Summary report: N

    FITMORE HIP STEM B EXT. OFFS., SIZE 4

    MDR report key: 2860519 · Received December 5, 2012

    Report

    Report Number
    9613350-2012-01123
    Event Type
    Other
    Date Received
    December 5, 2012
    Date of Event
    May 27, 2011
    Report Date
    November 6, 2012
    Manufacturer
    ZIMMER GMBH
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE EXPLANTED DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. WHERE LOT NUMBERS WERE RECEIVED FOR THE EXPLANTED DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. THE CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. HOWEVER, THERE IS NO INDICATION FOR A PRODUCT FAILURE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND/OR THE DEVICE(S) BE RETURNED FOR EVALUATION AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE FILED. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AT THIS TIME AND ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT IS EXPERIENCING PAIN AND STILL HAS TO USE A CANE TO WALK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FITMORE HIP STEM B EXT. OFFS., SIZE 4 PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL JDI ZIMMER GMBH 2456363

    Patients

    Seq Age Sex Outcome Treatment
    1 Other