BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCS COMPLETE FEM POR L STD+

    MDR report key: 2993145 · Received March 7, 2013

    Report

    Report Number
    1818910-2013-13403
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    February 28, 2013
    Report Date
    February 28, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS
    Product Code
    NJL
    PMA / PMN Number
    PP830055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT CONCLUDES: FOLLOWING INVESTIGATION BY (B)(4), NOTIFICATION WAS RECEIVED THAT: ROOT CAUSE: UNDETERMINABLE, FROM THE LIMITED INFORMATION IT WAS NOT POSSIBLE TO DETERMINE THE REASON FOR THE REVISION. THE PERFORMANCE OF THE DUOFIX TRAYS WAS REVIEWED IN CAPA (B)(4) WITH CORRESPONDING HHES. PRODUCT PERFORMANCE WAS DEFINED AS ACCEPTABLE. IT IS LIKELY IN THIS CASE THAT SEVERAL FACTORS COMBINED ¿ SUCH AS PATIENT FACTORS, SURGICAL PROCEDURE, SURGICAL PROCESS AND IMPLANT DESIGN. THE COMPLAINT SHALL BE CLOSED WITH AN UNDETERMINED CONCLUSION; IT SHALL BE ENTERED ONTO THE COMPLAINTS DATABASE AND MONITORED THROUGH TREND ANALYSIS. SHOULD FURTHER INFORMATION BE RECEIVED, THEN THE COMPLAINT SHALL BE INVESTIGATED FURTHER.

    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.

    Description of Event or Problem · 1

    REASON FOR REVISION: PATIENT WAS EXPERIENCING PAIN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98133 LCS COMPLETE FEM POR L STD+ FEMORAL HEAD NJL DEPUY ORTHOPAEDICS 2776190

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention