BEUDAMED
    FDA Adverse Event Other Summary report: N

    NCB PP PROX FEM PLATE, R,15 H, L. 324MM

    MDR report key: 2933227 · Received January 8, 2013

    Report

    Report Number
    9613350-2013-01224
    Event Type
    Other
    Date Received
    January 8, 2013
    Date of Event
    December 14, 2012
    Report Date
    December 17, 2012
    Manufacturer
    ZIMMER GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR DID NOT RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. AS NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. THERE IS NO INDICATION FOR A PRODUCT FAILURE. WITH THE INFORMATION GIVEN SO FAR, NO FURTHER INVESTIGATION IS POSSIBLE. THE ROOT CAUSE FOR THIS EVENT CANNOT BE IDENTIFIED. SHOULD ADDITIONAL INFO BECOME AVAILABLE AND/OR THE DEVICE(S) BE RETURNED FOR EVAL 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 CLOSED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT PRESENTED WITH A BROKEN S&N HIP STEM. DURING REVISION SURGERY, THE FEMUR WAS SEVERELY DAMAGED AND THEREFORE ADDITIONAL TO A NEW STEM CABLE FOR STABILIZATION WERE IMPLANTED. IN A SECOND REVISION SURGERY ON (B)(6) 2012, A NCB PROXIMAL FEMUR PERIPROSTHETIC PLATE WAS IMPLANTED. DURING IMPLANTATION, THE DISTAL SCREWS WERE INSERTED TOO STEEP AND THE SURGEON HAD DIFFICULTIES TO BACK THE SCREWS OUT. THE SCREWS WERE REPLACED BY NEW ONES, BUT DURING POST-SURGICAL CONTROL OF THE X-RAYS, IT WAS NOTICED THAT TWO DISTAL SCREWS WERE PULLED THROUGH THE HOLES OF THE PLATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10397 NCB PP PROX FEM PLATE, R,15 H, L. 324MM NCB STRAIGHT NARROW SHAFT PLATES HRS ZIMMER GMBH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other
    2
    3