BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PFC*SIGMA C/R NPOR FEM RT SZ 3

    MDR report key: 5285945 · Received December 10, 2015

    Report

    Report Number
    1818910-2015-37190
    Event Type
    Malfunction
    Date Received
    December 10, 2015
    Date of Event
    November 14, 2015
    Report Date
    December 17, 2015
    Manufacturer
    DEPUY IRELAND ¿ REG. # 9616671
    Product Code
    JWH
    PMA / PMN Number
    PK943462
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THE INVESTIGATION ONCE IT HAS BEEN COMPLETED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4). FOLLOWUP WITH THE COMPLAINANT HAS BEEN CONDUCTED FOR THE LOT NUMBER, AND THE INFORMATION IS NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT REMAINS UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THE INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER REPORTED INCIDENT AGAINST EITHER OF THE PROVIDED PRODUCT / LOT COMBINATION SINCE RELEASE FOR DISTRIBUTION. ALL THE LOT 7799142 HAD BEEN DISTRIBUTED FROM THE EUROPEAN DISTRIBUTION CENTRE (EDC) PRIOR TO LOT 7988338 PRODUCTS ARRIVING. THIS TOGETHER WITH THE FACT THAT THERE WERE NO PRODUCT RETURNS TO THE EDC MEANT THAT IT WAS HIGHLY UNLIKELY THAT THERE WAS A PRODUCT MIX AT THE EDC. PRA 103265745 WAS CONDUCTED TO IDENTIFY ANY RISK TO PATIENT OR ANY REGULATORY RISK. IT WAS AGREED THAT THERE WAS NO RISK EITHER PATIENT OR REGULATORY. THE COMPLAINT SHALL BE CLOSED WITH A JUSTIFIED CONCLUSION. THE PRODUCT SHALL BE RETAINED AND STORED IN SECURE STORAGE AREA FOR FUTURE REFERENCE. THE OCCURRENCE SHALL BE PUT MONITORED THROUGH OUR COMPANIES POST MARKET SURVEILLANCE SYSTEM FOR FUTURE TRENDS. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED THE INVESTIGATION WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    (B)(4).THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DURING THE SURGERY, 960013 NUMBERED PROTHESIS WAS OPENED TO BE USED HOWEVER, 960058 NUMBERED PROTHESIS CAME OUT FROM THE BOX..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    816628 PFC*SIGMA C/R NPOR FEM RT SZ 3 KNEE FEMORAL COMPONENT JWH DEPUY IRELAND ¿ REG. # 9616671 7988338

    Patients

    Seq Age Sex Outcome Treatment
    1