BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 7813029 · Received August 24, 2018

    Report

    Report Number
    1818910-2018-67625
    Event Type
    Injury
    Date Received
    August 24, 2018
    Date of Event
    July 9, 2018
    Report Date
    July 9, 2018
    Manufacturer
    JJM (SUZHOU) LTD. 3006356043
    Product Code
    JWH
    UDI-DI
    10603295232667
    PMA / PMN Number
    K884796
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). 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. DEVICE HISTORY LOT: PRODUCT CODE 960111, LOT NUMBER D11061259. DEVICE HISTORY BATCH: NULL. DEVICE HISTORY REVIEW: DHR REVIEW. PRODUCT CODE 960111, WORK ORDER /LOT NO. D11061259 WAS MANUFACTURED ON 29-JUN-2011. ONE HUNDRED AND TWENTY 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

    IT WAS REPORTED THAT THE PATIENT FELL AND LANDED ON HER LEFT KNEE. X-RAY'S SHOWED A DISRUPTION IN THE PATELLA/BONE INTERFACE. UPON OPEN EXPLORATION IT WAS DETERMINED THAT THE PATELLA COMPONENT WAS FRACTURED. LOOSENING OF THE PATELLA AT THE BONE/CEMENT INTERFACE. THE SURGEON ALSO ELECTED TO EXCHANGE THE TIBIAL INSERT TO A LARGE-THICKNESS. DOI: (B)(6) 2012; DOR: (B)(6) 2018; LEFT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653236 PFC*SIGMA/RD/DOME PAT 3PEG,35 SIGMA KNEE PRIMARY : KNEE PATELLA JWH JJM (SUZHOU) LTD. 3006356043 D11061259 10603295232667

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention