BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGMA STAB GVF INS 3 12.5MM

    MDR report key: 7805092 · Received August 22, 2018

    Report

    Report Number
    1818910-2018-67390
    Event Type
    Malfunction
    Date Received
    August 22, 2018
    Date of Event
    July 30, 2018
    Report Date
    July 31, 2018
    Manufacturer
    JJM (SUZHOU) LTD. 3006356043
    Product Code
    JWH
    UDI-DI
    10603295064268
    PMA / PMN Number
    K033272
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4).

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. 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. 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

    DEFLECTION PRODUCT DURING IMPLEMENTATION. TO PROCEDURE COMPLETED PHYSICIAN USED ANOTHER ONE PRODUCT THE SAME TYPE. NO CONSEQUENCES FOR THE PATIENT REPORTED.

    Description of Event or Problem · 1

    UPDATE ADDITIONAL INFORMATION RECEIVED: THERE WAS A LESS THAN 30 MINUTE SURGERY DELAY

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645850 SIGMA STAB GVF INS 3 12.5MM SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT JWH JJM (SUZHOU) LTD. 3006356043 D17030431 10603295064268

    Patients

    Seq Age Sex Outcome Treatment
    1