BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-05343

    MDR report key: 3311547 · Received August 27, 2013

    Report

    Report Number
    2520274-2013-05343
    Event Type
    Injury
    Date Received
    August 27, 2013
    Date of Event
    June 12, 2013
    Report Date
    June 19, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR AN UNKNOWN DHS IMPLANT. DEVICE WAS IMPLANTED 1.5 YEARS PRIOR TO EXPLANT. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. SHOULD BE - THIS REPORT IS FOR AN UNKNOWN TI TIBIA PLATE. SHOULD BE - HRS, JEY.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE DYNAMIC HIP SYSTEM (DHS) WAS IMPLANTED 1.5 YEARS AGO. AFTER 1.5 YEARS THE IMPLANT WAS REMOVED DUE TO PATIENT PAIN. RUST WAS OBSERVED ON THE DHS IMPLANT AT THE TIME OF REMOVAL. THERE WAS NO PATIENT INFECTION. THIS PATIENT ALSO HAD A DISTAL TIBIA PLATE. THIS IMPLANT WAS REMOVED ON THE SAME DAY, AND DID NOT SHOW CORROSION. THIS REPORT IS FOR AN UNKNOWN TIBIA PLATE. THIS IS REPORT 2 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420310 HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention