BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC*SIGMA/OV/DOME PAT 3PEG,41

    MDR report key: 6410933 · Received March 16, 2017

    Report

    Report Number
    1818910-2017-14807
    Event Type
    Injury
    Date Received
    March 16, 2017
    Date of Event
    February 28, 2017
    Report Date
    February 28, 2017
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JWH
    PMA / PMN Number
    K961685
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PROCEDURE: REVISION LEFT TOTAL KNEE REPLACEMENT- PATELLA COMPONENT ONLY. REP ATTENDED A REVISION LEFT TOTAL KNEE REPLACEMENT, PATELLA COMPONENT ONLY AT (B)(4) ON THE (B)(4) 2017 FOR CASE SUPPORT AS A COMPANY REPRESENTATIVE. SURGEON MENTIONED THE PATIENT HAD BEEN EXPERIENCING PAIN IN THE KNEE FOR MANY YEARS. SURGEON PERFORMED A KNEE ARTHROSCOPY TO ACCESS THE JOINT AND NOTED THAT THE FEMORAL, TIBIAL AND TIBIAL INSERT WERE SOUND AND IN GOOD CONDITION. THE PATELLA HAD SOME WORN MARKS. THERE WERE NO LOOSE BODIES OR ANY OTHER SIGNS THAT COULD INDICATE CAUSE FOR THE PATIENT'S PAIN. SURGEON OPENED THE KNEE AND REPLACED THE PFC SIGMA PATELLA. SURGEON DID NOTE AND EXPRESS THAT HE THOUGHT THE PRIMARY PATELLA ALIGNMENT WAS NOT IDEAL. A NEW 41MM PFC PATELLA 41MM LARGE OVAL WAS IMPLANTED REF: 962051, LOT: D16092456. PRIMARY IMPLANT WAS ON (B)(6) 2009. 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.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THE INVESTIGATION ONCE IT HAS BEEN COMPLETED. (B)(4). FOLLOWUP WITH THE COMPLAINANT HAS BEEN CONDUCTED FOR THE LOT NUMBER, AND THE INFORMATION IS NOT AVAILABLE. 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

    SURGEON MENTIONED THE PATIENT HAD BEEN EXPERIENCING PAIN IN THE KNEE FOR MANY YEARS. SURGEON PERFORMED A KNEE ARTHROSCOPY TO ACCESS THE JOINT AND NOTED THAT THE FEMORAL, TIBIAL AND TIBIAL INSERT WERE SOUND AND IN GOOD CONDITION. THE PATELLA HAD SOME WORN MARKS. THERE WERE NO LOOSE BODIES OR ANY OTHER SIGNS THAT COULD INDICATE CAUSE FOR THE PATIENT'S PAIN. SURGEON OPENED THE KNEE AND REPLACED THE PFC SIGMA PATELLA. SURGEON DID NOTE AND EXPRESS THAT HE THOUGHT THE PRIMARY PATELLA ALIGNMENT WAS NOT IDEAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193723 PFC*SIGMA/OV/DOME PAT 3PEG,41 KNEE PATELLAR COMPONENT JWH DEPUY ORTHOPAEDICS, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention