BEUDAMED
    FDA Adverse Event Injury Summary report: N

    135 DEG LCP® DHHS(TM) SIDEPLATE-STD BARREL 4 HOLES

    MDR report key: 3221031 · Received July 11, 2013

    Report

    Report Number
    3003506883-2013-00300
    Event Type
    Injury
    Date Received
    July 11, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 24, 2013
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    KTT
    PMA / PMN Number
    K033556
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE WAS RETURNED FOR EVALUATION. (B)(4). A PRODUCT DEVELOPMENT EVENT EVALUATION WAS CONDUCTED AND THE REPORT INDICATES THE PROBABLE CAUSE OF THIS COMPLAINT IS FAILURE TO FOLLOW PROPER TECHNIQUE. STEP 6 ON THE TECHNIQUE GUIDE PROVIDES DETAIL INSTRUCTIONS ON USING THE ALIGNMENT SHAFT (338.342) TO ALIGN THE KEY OF THE SIDE PLATE WITH THE HELICAL BLADE SHAFT. IF THIS STEP IS NOT FOLLOWED THE KEY OF THE SIDE PLATE WOULD NOT ALIGN AND COULD JAM WITH THE SHAFT OF THE HELICAL BLADE WHEN THE PATIENT WEIGHT BEARING ON THE DEVICE. THE SIDE PLATE AND HELICAL BLADE DESIGNS WERE REVIEWED AND DETERMINED TO MEET THE INTENDED USE.

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN WHEN THE PATIENT STARTED TO FEEL THE PAIN. THEREFORE, THE EVENT DATE IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT SUFFERED A RIGHT INTERTROCHANTERIC (IT) FRACTURE, SUBTROCHANTERIC FRACTURE IN (B)(6). SURGERY WAS PERFORMED WITH A DYNAMIC HELICAL HIP SYSTEM SIDE PLATE AND HELICAL HIP SCREW. IT WAS REPORTED THAT THE HELICAL BLADE HAD MIGRATED INTO THE ACETABULUM OF THE PATIENT AND NEEDED TO BE REMOVED. SURGERY WAS PLANNED FOR (B)(6)2013. THE ENTIRE CONSTRUCT WAS VERY EASILY REMOVED AND RE-IMPLANTED A 4.5MM LOCKING COMPRESSION PROXIMAL FEMUR PLATE. THE PATIENT HAD PAIN FROM IMPLANT FAILURE. REVISION SURGERY WENT WELL AND THE SURGEON WAS HAPPY WITH THE NEW IMPLANT PLACEMENT. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319502 135 DEG LCP® DHHS(TM) SIDEPLATE-STD BARREL 4 HOLES KTT SYNTHES ELMIRA 4783131

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention