BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGMA PS CEM FEM SZ4N R

    MDR report key: 3032554 · Received April 3, 2013

    Report

    Report Number
    1818910-2013-14813
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    August 24, 2012
    Report Date
    March 4, 2013
    Manufacturer
    DEPUY INTL., LTD. 8010379
    Product Code
    JWH
    PMA / PMN Number
    PK073529
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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 REPORTED EVENT 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 INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. BASED ON THE INABILITY TO IDENTIFY A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED DEPUY REGARDING SIGNIFICANT KNEE PAIN THEY WERE EXPERIENCING. PATIENT'S MEDICAL RECORDS WERE RECEIVED. RECORDS INDICATE THE PATIENT HAD PATELLA CLUNK TREATED WITH AN ARTHROSCOPY. FOLLOWING THE ARTHROSCOPY THE PATIENT WAS STILL EXPERIENCING SIGNIFICANT PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135603 SIGMA PS CEM FEM SZ4N R FEMORAL JWH DEPUY INTL., LTD. 8010379 FJ9DX4

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Unknown Required Intervention