BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTASUL-S-30-HEAD 28 L

    MDR report key: 3911551 · Received May 27, 2014

    Report

    Report Number
    9613350-2014-03543
    Event Type
    Injury
    Date Received
    May 27, 2014
    Date of Event
    January 21, 2014
    Report Date
    May 9, 2014
    Manufacturer
    ZIMMER GMBH
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. 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. (B)(4).

    Description of Event or Problem · 1

    A PT IS PURSUING A PRODUCT LIABILITY CLAIM AND AN ATTORNEY LETTER WAS RECEIVED. IT IS REPORTED THAT PT WAS IMPLANTED WITH A PROTASUL-S-30-HEAD 28 L IN (B)(6) 2011. AFTER SURGERY PT STARTS TO FEEL DISCOMFORT AND DUE TO POSSIBLE HIGH WEAR PT GOT A SYNOVIALITIS. IT IS ALSO REPORTED THAT DUE TO THE HEAVY SYNOVIALITIS (JOINT INFLAMMATION) PT WAS REVISED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311400 PROTASUL-S-30-HEAD 28 L PROTASUL-S-30-HEAD 28 L JDI ZIMMER GMBH NA 2626659

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R