BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRYKER RECON PLATE 14HL317485

    MDR report key: 3042752 · Received April 3, 2013

    Report

    Report Number
    MW5029648
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    March 25, 2013
    Report Date
    April 3, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS
    Product Code
    HRS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD A 14 HOLE STRYKER RECON PLATE PLACED TO THE LEFT FEMUR (FOLLOWING REMOVAL OF OLD PLATE AND SCREWS, WHICH WERE PLACED APPROX 50 YEARS AGO) ON (B)(6) 2013. PT HAD F/U XRAYS WHICH SHOWED GOOD HEALING AND NO EVIDENCE OF STRESS FRACTURES ON (B)(6) 2013. ON (B)(6) 2013, THE PT STATED THAT SHE HAD GONE TO CLOSE A WINDOW AND, UPON TURNING, DEVELOPED IMMEDIATE PAIN AND WAS NO LONGER ABLE TO AMBULATE. X-RAYS REVEALED A TRANSVERSE FRACTURE THROUGH THE MID FEMORAL SHAFT, AS WELL AS THROUGH THE OVERLYING SIDE PLATE, WITH MARKED MEDIAL AND POSTERIOR ANGULATION AT THE FRACTURE SITE. REPAIR OF THE FRACTURE REQUIRED THE PT TO RETURN TO SURGERY FOR REMOVAL OF THE PRESENT PLATE AND PLACEMENT OF A NEW PLATE ON (B)(6) 2013. PT WAS ALSO SUBSEQUENTLY HOSPITALIZED FROM (B)(6) - (B)(6) AND TRANSFERRED TO REHAB FOR CONTINUED TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136376 STRYKER RECON PLATE 14HL317485 STRYKER RECON PLATE HRS STRYKER ORTHOPAEDICS X27100

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| O