BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC*SIGMA/RD/DOME PAT 3PEG,35

    MDR report key: 3021231 · Received March 26, 2013

    Report

    Report Number
    1818910-2013-14454
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    February 20, 2013
    Report Date
    February 28, 2013
    Manufacturer
    DEPUY IRELAND ? REG. # 9616671
    Product Code
    JWH
    PMA / PMN Number
    PK884796
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 REMAINS IMPLANTED. NO REVISION SURGERY HAS BEEN REPORTED. THE INITIAL REPORTING STATED X-RAYS WERE NOT AVAILABLE FOR EXAMINATION. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATION SINCE ITS RELEASE FOR DISTRIBUTION. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE ROOT CAUSE OF THE REPORTED EVENT. NO EVIDENCE WAS FOUND SUGGESTING PRODUCT ERROR WAS A CONTRIBUTING FACTOR AND THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE DEVICE AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    CLINICAL REPORT STATE THE PATIENT HAD ADHESIONS, PAIN, LIMITED RANGE OF MOTION, LYSIS OF ADHESIONS AND DEBRIDEMENT, ARTHROFIBROSIS. THE PATIENT UNDERWENT AN ARTHROSCOPY, CLOSED REDUCTION/MANIPULATION, AND I & D.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123644 PFC*SIGMA/RD/DOME PAT 3PEG,35 PATELLA JWH DEPUY IRELAND ? REG. # 9616671 2994431

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention