BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ULNA GSB-III

    MDR report key: 5077522 · Received September 15, 2015

    Report

    Report Number
    9613350-2015-01295
    Event Type
    Injury
    Date Received
    September 15, 2015
    Date of Event
    August 20, 2015
    Report Date
    August 20, 2015
    Manufacturer
    ZIMMER GMBH
    Product Code
    JDC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. AS NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Additional Manufacturer Narrative · 1

    THE TREND REVIEW COULD NOT BE PERFORMED AS NO PRODUCT INFORMATION WAS PROVIDED. THE COMPATIBILITY CHECK COULD NOT BE PERFORMED AS NO PRODUCT INFORMATION WAS PROVIDED. A TECHNICAL INVESTIGATION WAS NOT POSSIBLE TO PERFORM, AS THE DEVICES WERE NOT AT HAND FOR INVESTIGATION. IT WAS REPORTED IN A MEDICAL JOURNAL THAT 15 PATIENTS RECEIVED AN UNKNOWN ULNA GSB-III ON UNKNOWN DATES. ACCORDING TO THE ARTICLE, THE PATIENTS WERE REVISED ON UNKNOWN DATES DUE TO EITHER ASEPTIC LOOSENING, PERIPROSTHETIC FRACTURE, PROSTHESIS DISLOCATION, INFECTION, FRACTURE OF PROSTHESIS OR LOOSE HINGE PIN. IT IS UNKNOWN WHICH AND HOW MANY PATIENTS EXPERIENCED WHICH COMPLICATION. THE INFORMATION IN THE JOURNAL ARTICLE WAS POOR. IN CONCLUSION, DUE TO SIGNIFICANT LACK OF INFORMATION, IT WAS IMPOSSIBLE TO PERFORM A MEANINGFUL ANALYSIS OF THE REPORTED EVENT. HOWEVER, THE POSSIBLE CAUSES FOR REVISION ARE COVERED IN THE DFMEA OT THE REPORTED DEVICE. BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, THE COMPLAINT COULD NOT BE CONFIRMED AS THE ALLEGED FAILURE COULD NOT BE IDENTIFIED OR REPRODUCED. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED IN A MEDICAL JOURNAL THAT 15 PATIENTS RECEIVED AN UNKNOWN ULNA GSB-III ON UNKNOWN DATES. ACCORDING TO THE ARTICLE, THE PATIENTS WERE REVISED ON UNKNOWN DATES DUE TO EITHER ASEPTIC LOOSENING, PERIPROSTHETIC FRACTURE, PROSTHESIS DISLOCATION, INFECTION, FRACTURE OF PROSTHESIS OR LOOSE HINGE PIN. IT IS UNKNOWN WHICH AND HOW MANY PATIENTS EXPERIENCED WHICH COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607863 UNKNOWN ULNA GSB-III GSB ELBOW JDC ZIMMER GMBH NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R