BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PFC*SIGMA/OV/DOME PAT 3PEG,35

    MDR report key: 8189507 · Received December 21, 2018

    Report

    Report Number
    1818910-2018-78993
    Event Type
    Malfunction
    Date Received
    December 21, 2018
    Date of Event
    December 11, 2017
    Report Date
    December 14, 2018
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    JWH
    UDI-DI
    10603295232612
    PMA / PMN Number
    K961685
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: EVALUATION OF THE RETURNED DEVICE/PACKAGING COMPONENTS 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. 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). INVESTIGATION SUMMARY: EVALUATION OF THE RETURNED DEVICE/PACKAGING COMPONENTS 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 960101, LOT NUMBER 8655613. DEVICE HISTORY REVIEW: DHR REVIEW PRODUCT CODE 960101, WORK ORDER (B)(4) WAS MANUFACTURED ON (B)(4) 2017. 35 PARTS OF SIGMA PATELLA (35MM) WERE MANUFACTURED PER SPECIFICATION AND ALL RAW MATERIALS MET SPECIFICATION. THERE ARE NO NCS OR DEVIATIONS ASSOCIATED WITH THIS LOT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH , A FOLLOW-UP MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DER STATES SIGMA OVAL DOME 35MM PATELLA OUTSIDE PEEL PACKAGING HAD A SLICE IN THE OUTER EDGE THAT WENT INTO THE INNER PORTION OF THE PACKAGING. STERILITY COULD NOT BE CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1030481 PFC*SIGMA/OV/DOME PAT 3PEG,35 SIGMA KNEE PRIMARY : KNEE PATELLA JWH DEPUY ORTHOPAEDICS, INC. 1818910 8655613 10603295232612

    Patients

    Seq Age Sex Outcome Treatment
    1