BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGMA STAB GVF INS 2.5 10MM

    MDR report key: 10529226 · Received September 14, 2020

    Report

    Report Number
    1818910-2020-19977
    Event Type
    Injury
    Date Received
    September 14, 2020
    Date of Event
    June 5, 2020
    Report Date
    August 31, 2020
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    UDI-DI
    10603295064091
    PMA / PMN Number
    K033272
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE LOT SPECIFIC COMPLAINT DATABASE SEARCH, OR DEVICE HISTORY RECORD (DHR) REVIEW, WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT NUMBER WAS NOT PROVIDED. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. CORRECTED H6 PATIENT CODE: NO CODE AVAILABLE (3191) FROM THE INITIAL MEDWATCH TO CAPTURE PATIENT HARM JOINT INSTABILITY

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    ADVERSE EVENT DESCRIPTION: KNEE REVISION TO ADDRESS PAINFUL LEFT KNEE ARTHROPLASTY WITH MID FLEXION INSTABILITY AND RECURVATUM DEFORMITY ADDITIONAL INFORMATION FOLLOW-UP REQUEST MEDICAL RECORDS INDICATED THE FOLLOWING WITH RESPECT TO THE PATIENT'S LEFT, NON-STUDY TOTAL KNEE ARTHROPLASTY. THE OPERATIVE RECORDS INDICATE THAT THE PATIENT HAD RECEIVED A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2016, TO ADDRESS OSTEOARTHRITIS. IT WAS NOTED THAT THE PATIENT WAS MORBIDLY OBESE, WITH A BMI OF 47. THERE WERE NO REPORTED INTRAOPERATIVE OR POST-OPERATIVE COMPLICATIONS ASSOCIATED WITH THIS PRIMARY KNEE ARTHROPLASTY. ON (B)(6) 2020, PATIENT'S LEFT KNEE WAS REVISED TO ADDRESS PAINFUL LEFT KNEE WITH MID-FLEXION INSTABILITY AND RECURVATUM DEFORMITY. AT THIS TIME, THE PATIENT WAS STILL MORBIDLY OBESE, AS THE PATIENT'S BMI WAS NOW 52. THERE WAS NO EVIDENCE OF INFECTION OR IMPLANT LOOSENING IDENTIFIED. SCAR TISSUE WAS EXCISED. IT WAS OBSERVED THAT BECAUSE OF THE RECURVATUM DEFORMITY (OF 15 DEGREES IN FULL EXTENSION), THE POST OF THE STABILIZED INSERT WAS IMPINGING ON THE BOX OF THE FEMORAL COMPONENT, LEADING TO SOME DAMAGE OF THE POLYETHYLENE INSERT POST. A PFC SIGMA FIXED BEARING STABILIZED TIBIAL INSERT, SIZE 2.5 X 15MM THICK WAS IMPLANTED TO ACHIEVE CORRECTION OF THE RECURVATUM DEFORMITY AND THE MID-FLEXION INSTABILITY. ALL OTHER PRODUCTS WERE RETAINED. PATIENT'S SURGERY WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2016 DOR: (B)(6) 2020 (LEFT KNEE).

    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.

    Description of Event or Problem · 1

    (B)(6). ADVERSE EVENT DESCRIPTION: KNEE REVISION TO ADDRESS PAINFUL LEFT KNEE ARTHROPLASTY WITH MID FLEXION INSTABILITY AND RECURVATUM DEFORMITY. ADDITIONAL INFORMATION FOLLOW-UP REQUEST MEDICAL RECORDS INDICATED THE FOLLOWING WITH RESPECT TO THE PATIENT'S LEFT, NON-STUDY TOTAL KNEE ARTHROPLASTY. THE OPERATIVE RECORDS INDICATE THAT THE PATIENT HAD RECEIVED A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2016, TO ADDRESS OSTEOARTHRITIS. IT WAS NOTED THAT THE PATIENT WAS MORBIDLY OBESE, WITH A BMI OF 47. THERE WERE NO REPORTED INTRAOPERATIVE OR POST-OPERATIVE COMPLICATIONS ASSOCIATED WITH THIS PRIMARY KNEE ARTHROPLASTY. THE FOLLOWING PRODUCTS WERE IMPLANTED: J&J SIGMA CRUCIATE SUBSTITUTING SIZE 3 LEFT FEMUR COMPONENT (PRODUCT #: 196040300), J&J SIGMA MODULAR TIBIAL TRAY SIZE 2.5 COMPONENT (PRODUCT #: 158125000), J&J SIGMA ALL POLY 3 PEG SIZE 35MM OVAL DOME PATELLA COMPONENT (PRODUCT #: 960101), AND J&J SIGMA STABILIZED TIBIAL INSERT SIZE 2.5, 10MM THICK (PRODUCT #: 158122010). ON (B)(6) 2020, PATIENT'S LEFT KNEE WAS REVISED TO ADDRESS PAINFUL LEFT KNEE WITH MID-FLEXION INSTABILITY AND RECURVATUM DEFORMITY. AT THIS TIME, THE PATIENT WAS STILL MORBIDLY OBESE, AS THE PATIENT'S BMI WAS NOW 52. THERE WAS NO EVIDENCE OF INFECTION OR IMPLANT LOOSENING IDENTIFIED. SCAR TISSUE WAS EXCISED. IT WAS OBSERVED THAT BECAUSE OF THE RECURVATUM DEFORMITY (OF 15 DEGREES IN FULL EXTENSION), THE POST OF THE STABILIZED INSERT WAS IMPINGING ON THE BOX OF THE FEMORAL COMPONENT, LEADING TO SOME DAMAGE OF THE POLYETHYLENE INSERT POST. A PFC SIGMA FIXED BEARING STABILIZED TIBIAL INSERT, SIZE 2.5 X 15MM THICK WAS IMPLANTED TO ACHIEVE CORRECTION OF THE RECURVATUM DEFORMITY AND THE MID-FLEXION INSTABILITY. ALL OTHER PRODUCTS WERE RETAINED. PATIENT'S SURGERY WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2016, DOR: (B)(6) 2020, (LEFT KNEE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    993200 SIGMA STAB GVF INS 2.5 10MM SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT JWH DEPUY ORTHOPAEDICS INC US 1581-22-010 10603295064091

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention PFC*SIGMA/OV/DOME PAT 3PEG,35| SIG MOD TIB TRAY CEM COCR 2.5| SIGMA PS CEM FEM SZ3 L| SIGMA STAB GVF INS 2.5 10MM