BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZ 3 LEFT

    MDR report key: 6947958 · Received October 13, 2017

    Report

    Report Number
    3005180920-2017-00585
    Event Type
    Injury
    Date Received
    October 13, 2017
    Report Date
    October 13, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030825811
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE SECOND REVISION SURGERY UNDERWENT BY THE PATIENT. SHE HAD A PRIMARY SURGERY ON (B)(6) 2016. THE PATIENT WAS REVISED THE FIRST TIME ON (B)(6) 2017 AS THE PATIENT LACKED FLEXION. THE SURGEON REMOVED THE CEMENTED PATELLA AS WELL AS 3-4MM OF BONE, 120 DAYS AFTER PRIMARY. THE SURGEON IMPLANTED A SIZE 3 PATELLA AND PERFORMED A LATERAL RELEASE TO EASE SOFT TISSUE TENSION. THE SURGERY WAS COMPLETED SUCCESSFULLY. THEN, THE PATIENT UNDERWENT THE SUBJECT REVISION SURGERY. ON (B)(6) 2017 THE PATIENT MATCH DEPARTMENT PROVIDED A PLANNING REVIEW OF THIS CASE, REPORTING AS FOLLOWS: OUR ANALYSIS OF THE PLANNING PROCESS OF THIS CASE FOUND NO DEVIATIONS FROM THE STANDARD PROCEDURES. EACH STEP HAS BEEN PERFORMED CORRECTLY. BATCH REVIEW PERFORMED ON (B)(6) 2017. LOT 162327: (B)(4) ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2016. EXPIRATION DATE: 2021-09-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ON 13 OCTOBER 2017 THE MEDICAL AFFAIRS DIRECTOR PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: REVISION SURGERY OF PRIMARY CEMENTED TKA IMPLANTED (B)(6) TOOK PLACE TWICE: THE FIRST TIME A CORRECTION OF PATELLAR RESURFACING AND LIGAMENT RELEASE WERE PERFORMED (NOT OBJECT OF THIS COMPLAINT); THE SECOND TIME REQUIRED EXPLANT OF FEMORAL COMPONENT AND REPOSITIONING. FROM THE X-RAY SUPPLIED, THE FEMORAL COMPONENT APPEARS IN FACT TO BE MALROTATED (WE CANNOT DETERMINE IF IT WAS INTERNALLY OR EXTERNALLY ROTATED) AND THEREFORE FLEXION AND PATELLA TRACKING COULD BE COMPROMISED. THE PROBLEM SEEMS TO HAVE BEEN ORIGINATED BY A TECHNICAL PROBLEM DURING FIRST SURGERY, ORIGIN UNKNOWN, AND WE SEE NO EVIDENCE THAT IT COULD BE RELATED TO A FAULTY DEVICE.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT AN ADDITIONAL SURGERY ON (B)(6) 2017 BECAUSE THE FEMUR WAS MALROTATED. THE SURGEON REVISED THE FEMORAL COMPONENT AND THE INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727306 GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZ 3 LEFT FEMORAL COMPONENT CEMENTED JWH MEDACTA INTERNATIONAL SA 165037 07630030825811

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention