BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11.0MM TI HELICAL BLADE 100MM

    MDR report key: 2852564 · Received November 30, 2012

    Report

    Report Number
    3003506883-2012-00376
    Event Type
    Injury
    Date Received
    November 30, 2012
    Report Date
    November 3, 2012
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HSB
    PMA / PMN Number
    K011857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF 11 MM TI HELICAL BLADES WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD REVEALED THIS LOT MET ALL SPECIFICATIONS WITH NO ANOMALIES NOTED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED REGARDING A HELICAL BLADE IMPLANT. THE DATE OF THE IMPLANT IS UNKNOWN. POST-OPERATIVELY, THE PATIENT PRESENTED WITH HIP PAIN. THE SURGEON REPORTED THAT AN X-RAY REVEALED THE HELICAL BLADE WAS PROTRUDING INTO THE ACETABULAR JOINT, CAUSING THE PAIN. ON (B)(6) 2012, THE HARDWARE WAS REMOVED AND THE PATIENT WAS REVISED TO A TOTAL HIP. THIS IS REPORT # 1 OF 2 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 11.0MM TI HELICAL BLADE 100MM HELICAL BLADE HSB SYNTHES ELMIRA 6967218

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention