BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC SIGMA STAB+ INS 10MM SZ2

    MDR report key: 7071666 · Received November 30, 2017

    Report

    Report Number
    1818910-2017-50461
    Event Type
    Injury
    Date Received
    November 30, 2017
    Date of Event
    September 25, 2017
    Report Date
    October 31, 2017
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    JWH
    UDI-DI
    10603295243885
    PMA / PMN Number
    K950010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY: REVIEW OF THE PROVIDED EXPLANT PHOTOGRAPH CONFIRMS THE REPORTED EVENT. 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. DEVICE HISTORY LOT: PRODUCT CODE 962710, LOT NUMBER ED6L74. DEVICE HISTORY BATCH: NULL. DEVICE HISTORY REVIEW : DHR REVIEWED - NO NONCONFORMANCES WERE NOTED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    PATIENT INITIATED COMPLAINT; MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE PATIENT WAS REVISED FOR TIBIAL MALPOSITIONING, POLY WEAR, METALLOSIS, AND FEMORAL LOOSENING AT AN UNKNOWN INTERFACE/CEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850120 PFC SIGMA STAB+ INS 10MM SZ2 TIBIAL INSERT JWH DEPUY IRELAND - 9616671 ED6L74 10603295243885

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention