BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL PLATE 6 HOLE RIGHT

    MDR report key: 1770292 · Received July 21, 2010

    Report

    Report Number
    1818910-2010-04754
    Event Type
    Injury
    Date Received
    July 21, 2010
    Date of Event
    June 23, 2010
    Report Date
    June 23, 2010
    Manufacturer
    DEPUY ACE S.A.'R.L.
    Product Code
    HRS
    PMA / PMN Number
    K060969
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO PRIOR REPORTS FOR THIS PART AND LOT NUMBER COMBINATION. REVIEW OF THE AS400 SYSTEM SHOW THAT 14 OTHER DEVICES FROM LOT DKGBBW HAVE BEEN DELIVERED AND CAN BE REASONABLY CONCLUDED IMPLANTED WITHOUT ISSUE AS NO FURTHER REPORTS ARE IDENTIFIED. PROVIDED INFORMATION MARKED ON THE DEVICE EXPERIENCE REPORT IS MARKED THAT THE PRODUCTS ARE NOT SUSPECTED OF FAILING TO MEET SPECIFICATIONS OR CONTRIBUTING TO THE REPORTED EVENT. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PT WAS REVISED TO ADDRESS PAINFUL HARDWARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FEMORAL PLATE 6 HOLE RIGHT 87HRS HRS DEPUY ACE S.A.'R.L. NA DKGBBW

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention