BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PE INSERT FF/28

    MDR report key: 3931536 · Received June 23, 2014

    Report

    Report Number
    9613350-2014-03639
    Event Type
    Injury
    Date Received
    June 23, 2014
    Date of Event
    April 25, 2014
    Report Date
    June 2, 2014
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THIS REPORT, THE MANUFACTURER DID NOT RECEIVE AFFECTED DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW, THOUGH THE LOT NUMBERS WERE RECEIVED FOR THE DEVICES. THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. ONCE THE DEVICES ARE RECEIVED AND INVESTIGATED AND THE RESULT OF THE INVESTIGATION IS MADE AVAILABLE, AN UPDATED REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT RECEIVED A POLYETHYLENE STANDARD INLAY FF/28, LEFT SIDE, ON (B)(6) 2005. ON (B)(6) 2014, THE PT COMPLAINED OF CRACKING SOUND COMING FROM HER LEFT HIP. SINCE THEN, THE PT SUFFERED CONSTANT PAIN AND SHE HAD DIFFICULTY WALKING AND WALKED WITH THE AID OF 2 WALKING CANES. THE PT UNDERWENT REVISION SURGERY ON (B)(6) 2014 AND THE FINDINGS WERE THAT THERE WAS A SPONTANEOUS PERFORATION OF THE LEFT HIP ACETABULAR PROSTHESIS. THE METAL HEAD WENT THROUGH THE PE INSERT AND THE METALBACK. THE SURGERY WAS TO CHANGE THE ACETABULAR COMPONENTS AND ACETABULAR RECONSTRUCTION WITH METAL CROSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364573 PE INSERT FF/28 PE INSERT STANDARD KWA ZIMMER GMBH 2090018

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R