BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGTIBCEMSTM 13X30 1.5/2/2.5/3

    MDR report key: 7224343 · Received January 29, 2018

    Report

    Report Number
    1818910-2018-52226
    Event Type
    Malfunction
    Date Received
    January 29, 2018
    Date of Event
    January 10, 2018
    Report Date
    January 10, 2018
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    JWH
    UDI-DI
    10603295216896
    PMA / PMN Number
    K882234
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 # PC-(B)(4). INVESTIGATION SUMMARY: EVALUATION OF THE RETURNED DEVICE WAS UNABLE TO CONFIRM 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: PRODUCT CODE (B)(4) LOT NUMBER D17093530. DEVICE HISTORY REVIEW: PRODUCT CODE (B)(4), LOT NO. D17093530 WAS MANUFACTURED ON (B)(4) 2017. 61 PARTS WERE MANUFACTURED PER SPECIFICATION AND ALL RAW MATERIALS MET SPECIFICATION. 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

    DER STATES THAT THE TIBIAL TRAY AND 13X30 CEMENTED STEM WOULD NOT THREAD ALL OF THE WAY DOWN. DOE: (B)(6) 2018. UNKNOWN KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68606 SIGTIBCEMSTM 13X30 1.5/2/2.5/3 KNEE STEMS JWH DEPUY ORTHOPAEDICS, INC. 1818910 D17093530 10603295216896

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR