BEUDAMED
    FDA Adverse Event Other Summary report: N

    CERSASUL ALPHA INSERT NEUTRAL MM/28

    MDR report key: 3935935 · Received June 17, 2014

    Report

    Report Number
    9613350-2014-03616
    Event Type
    Other
    Date Received
    June 17, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 26, 2014
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR 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 INFO PROVIDED. SHOULD ADDITIONAL INFO 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).

    Description of Event or Problem · 1

    ZIMMER RECEIVED ON (B)(6) 2014 FROM (B)(6) A USER REPORT REGARDING A BREAKAGE OF A CERASUL ALPHA INSERT NEUTRAL MM/28. THER USER REPORT (B)(6) STATES: "A BREAKAGE OF A CERASUL INLAY HAS OCCURRED. IT IS REPORTED SINCE FOUR YEARS AGO, PT PRESENTED WITH INTERMITTENT DISCOMFORT. IT IS ALSO REPORTED APPROXIMATELY 1.5 YEARS AGO, PT DID A JUMP ABOUT 1,5 METERS HEIGHT, DID NOT LEAD IN DISCOMFORT BECAME WORSE. NO OTHER TRAUMA WAS REPORTED." AT THIS TIME, ACCORDING TO THE AVAILABLE INFO AND DOCUMENTS IT IS UNCLEAR IF A REVISION SURGERY HAS TAKEN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356263 CERSASUL ALPHA INSERT NEUTRAL MM/28 CERSASUL ALPHA INSERT NEUTRAL MM/28 LZO ZIMMER GMBH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other