BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T4-I3 R

    MDR report key: 7804986 · Received August 22, 2018

    Report

    Report Number
    3005180920-2018-00627
    Event Type
    Injury
    Date Received
    August 22, 2018
    Date of Event
    July 23, 2018
    Report Date
    November 15, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030827167
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATE OCTOBER 17, 2018. THE CASE IS NOT GOING TO BE REVISED WITH MEDACTA PRODUCTS ACCORDING TO THE SECRETARY.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2018 BY SALES REPRESENTATIVE THE SECOND STAGE REVISION HAS NOT HAPPENED YET. THE PATIENT REFUSES TO RELEASE HIS RESULTS ABOUT WHETHER IT IS INFECTION OR NOT. THE SURGEON INDICATED THAT THE SECOND STEP REVISION MAY BE IN ROUGHLY 6 MONTHS. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR ON (B)(6) 2018 FEW MONTHS AFTER PRIMARY CEMENTED TKA THE PATIENT WAS REVISED FOR PAIN. ALIGNMENT OF THE COMPONENTS LOOKED SUBOPTIMAL AT STATIC XRAYS IN UNCERTAIN PATIENT POSTURE, BUT DURING REVISION SURGERY INFECTION WAS SUSPECTED AND A TWO-STAGE REVISION UNDERTAKEN. FROM THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A FAULTY DEVICE AND THE MOST LIKELY CAUSE FOR THE ADVERSE EVENT SEEMS TO BE INFECTION. INVESTIGATION PERFORMED BY PATIENT MATCH DEPARTMENT ON (B)(6) 2018 OUR ANALYSIS OF THE MY KNEE PROCESS OF THIS CASE FOUND NO DEVIATIONS FROM THE STANDARD PROCEDURES. EACH STEP HAS BEEN PERFORMED CORRECTLY. BATCH REVIEW PERFORMED ON (B)(6) 2018 LOT 163353: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26 JULY 2016. EXPIRATION DATE: 2021-06-13 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. OTHER DEVICES INVOLVED: REFERENCE (B)(4) (K121416) TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/10 MM R LOT 172812: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13 JULY 2017. EXPIRATION DATE: 2022-06-29 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. REFERENCE (B)(4) (K140826) FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ R LOT 171830: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19 JULY 2017. EXPIRATION DATE: 2022-07-11 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.

    Description of Event or Problem · 1

    THE TIBIAL TRAY WAS FOUND INTERNALLY ROTATED 8 MONTHS AFTER PRIMARY. SURGEON PLANNED TO TAKE IT OUT AND REALIGN THE BASE PLATE FOR BETTER KNEE ALIGNMENT. DURING REVISION THE SURGEON SUSPECTED INFECTION AS THERE WAS SYNOVIAL FLUID BEHIND THE CEMENT. THE FEMORAL BONE WAS ALSO REALLY SOFT. HE DECIDED TO DO A 2 STAGE REVISION: ALL THE IMPLANTS WERE REMOVED AND THE SPECIMENS SENT FOR ANALYSIS. HE TEMPORARILY PUT THE FEMUR BACK IN WITH ANTIBIOTIC CEMENT AND CEMENTED (TEMPORARILY) THE POLY. THE SURGEON ALSO VOICED THAT THE FEMUR COMPONENT SEEMED MORE INTERNALLY ROTATED AND THE TIBIAL COMPONENT ALSO MALROTATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647093 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T4-I3 R TIBIAL TRAY FIXED CEMENTED JWH MEDACTA INTERNATIONAL SA 163353 07630030827167

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention