BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIG C/R POROCOAT FEM LT SZ 4

    MDR report key: 3120413 · Received May 20, 2013

    Report

    Report Number
    1818910-2013-17391
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 3, 2013
    Manufacturer
    1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC
    Product Code
    JWH
    PMA / PMN Number
    PK961685
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORTED EVENT IS ASSUMED TO REMAIN IMPLANTED AS NO REVISION SURGERY HAS BEEN REPORTED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENTS WITH THE NEWLY SUPPLIED INFORMATION. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATION SINCE ITS RELEASE FOR DISTRIBUTION. THE INITIAL REPORTING STATED RADIOGRAPHIC INFORMATION WAS NOT AVAILABLE FOR EXAMINE. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    CLINICAL REPORT STATES THE PATIENT HAD A TENDON RUPTURE. VASTUS MEDIALIS OBLIQUUS AVULSION FROM THE LEFT QUADRICEPS TENDON. THE PATIENT WAS TREATED WITH A SUTURED PATELLA TENDON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221918 SIG C/R POROCOAT FEM LT SZ 4 FEMORAL JWH 1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC 193501

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention