BEUDAMED
    FDA Adverse Event Injury Summary report: N

    24MM COCR RADIAL HEAD 2MM HT EXTENSION/15.0MM-STER

    MDR report key: 3164398 · Received June 12, 2013

    Report

    Report Number
    2520274-2013-03323
    Event Type
    Injury
    Date Received
    June 12, 2013
    Report Date
    May 15, 2013
    Manufacturer
    SYNTHES (U.S.A.)
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    IMPLANT DATE - UNKNOWN DATE IN (B)(6) 2012. A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR LOT # 6873715 REVEALED THE RADIAL HEAD EXTENSION HAD NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THIS INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RETURNED. PLACEHOLDER.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH RADIAL HEAD PLATE CONSTRUCT SEVERAL MONTHS AGO ON AN UNKNOWN DATE IN (B)(6) 2012. REPORTEDLY THE PATIENT IS COMPLAINT OF PAIN. THE SURGEON REPORTED THAT THE SELECTED IMPLANT HEAD MAY POTENTIALLY BE TOO LARGE (OVERSTUFFED) AND THE SURGEON BELIEVES THAT THIS IS THE ROOT CAUSE OF THE PAIN. PATIENT WAS RETURNED TO THE OPERATING ROOM ON AN UNSPECIFIED DATE FOR REVISION SURGERY. DURING THE REVISION SURGERY IT WAS NOTED THAT A SMALLER PROSTHESIS WAS UNNECESSARY SINCE THE ORIGINAL IMPLANT SETTLED WITHIN THE JOINT AND THERE WAS NO OVERCROWDING. SINCE THE JOINT WAS STABLE, REPORTEDLY THE ORIGINAL IMPLANT WAS REMOVED AND THE PARTS WERE DISCARDED; HOWEVER, IF THE ELBOW JOINT BECOMES UNSTABLE, THEN A SMALLER RADIAL HEAD PROSTHESIS WILL BE USED IN THE FUTURE. THE SURGEON BELIEVES THAT THE PAIN THE PATIENT IS EXPERIENCING IS DUE TO EITHER A LOW PAIN THRESHOLD OR RESIDUAL PAIN FROM THE ELBOW JOINT RECONSTRUCTION. THIS REPORT IS FOR AN UNKNOWN RADIAL HEAD IMPLANT. THIS IS 1 OF 1 REPORT FOR COMPLAINT #(B)(4).

    Description of Event or Problem · 1

    UPDATE: THE DATE OF PATIENT INJURY WAS (B)(6) 2012. THIS IS 1 OF 1 DEVICES FOR THIS EVENT REPORTED ON COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266859 24MM COCR RADIAL HEAD 2MM HT EXTENSION/15.0MM-STER HRS SYNTHES (U.S.A.) 6956151

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention