BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 2 L

    MDR report key: 9149642 · Received October 3, 2019

    Report

    Report Number
    3005180920-2019-00826
    Event Type
    Injury
    Date Received
    October 3, 2019
    Date of Event
    September 4, 2019
    Report Date
    December 19, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819865
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIALLY THE REVISION WAS PERFORMED FOR A SUSPECTED TIBIAL TRAY LOOSENING, HOWEVER, ONCE THAT PATIENT WAS OPENED, THE SURGEON DID NOT SEE ANY SIGN OF LOOSENING BUT DECIDED TO REVISE TIBIAL TRAY AND THE TIBIAL INSERT. HE ALSO INSERTED A AN EXTENSION STEM IN THE TIBIA. SO THE REASON OF PATIENT PAIN REMAINS UNKNOWN. DATE OF PRIMARY IS (B)(6) 2018 AND NOT (B)(6) 2018 AS REPORTED IN THE INITIAL MDR. BATCH REVIEW PERFORMED ON 09 SEPTEMBER 2019: LOT 170413: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-MAY-2017. EXPIRATION DATE: 2022-04-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ADDITIONAL DEVICES INVOLVED IN THE COMPLAINT. BATCH REVIEWS PERFORMED ON 09 SEPTEMBER 2019: GMK-SPHERE 02.12.0210FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/10 MM L (K121416) LOT 173757: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-JUL-2017. EXPIRATION DATE: 2022-07-04. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT GMK-SPHERE 02.07.F11066 PRIMARY EXTENSION STEM Ø11MM / L 65 MM (K121416) LOT 166105: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-DEC-2016. EXPIRATION DATE: 2021-11-29. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION PERFORMED BY MEDACTA R&D KNEE MANAGER: PATIENT UNDERWENT A REVISION SURGERY 1 YEAR AFTER PRIMARY DUE TO PERIPROSTHETIC FRACTURE. 1 YEAR AND 9 MONTHS AFTER REVISION SURGERY, PATIENT WAS REVISED AGAIN FOR PAIN. REVISION SURGERY, WITH THE SUSPECT OF TIBIA LOOSENING, WAS PERFORMED. NO INFECTION HAS BEEN NOTED. EXPLANTED TIBIAL BASEPLATE WITH 5MM CEMENTED TIBIAL AUGMENT AND EXTENSION STEM D11/L65 HAS BEEN RETURNED. SOME RESIDUAL CEMENT CAN BE FOUND ON THE MEDIAL DISTAL SURFACE OF THE BASEPLATE AND THE AUGMENT. NO RESIDUAL CEMENT CAN BE FOUND ON THE LATERAL DISTAL SURFACE OF THE TIBIAL TRAY. NO OTHER CONSIDERATIONS RELEVANT FOR THE EVENT CAN BE NOTED FROM VISUAL INSPECTION. IT IS NOT POSSIBLE TO DETERMINE CAUSES FOR LOOSENING FROM VISUAL INSPECTION. CAUSE FOR LOOSENING AND MOBILIZATION CAN BE RELATED TO BONE FRACTURE, IMPLANT POSITIONING OR POOR CEMENT INTERDIGITATION NOT RELATED TO THE IMPLANT. THERE IS NO REASON TO SUSPECT THAT THE EVENT IS RELATED TO A FAULTY DEVICE.

    Description of Event or Problem · 0

    DEVICE RECEIVED ON THE 21 NOVEMBER 2019 AND ANALYZED ON THE 28 NOVEMBER 2019.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 09 SEPTEMBER 2019: LOT 170413: 80 ITEMS MANUFACTURED AND RELEASED ON 04-MAY-2017. EXPIRATION DATE: 2022-04-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 76 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ANOTHER SIMILAR REPORTED EVENT. CLINICAL EVALUATION: 1,5 YEARS AFTER REVISION TKA FOLLOWING A TRAUMATIC PERIPROSTHETIC FRACTURE, THE TIBIAL TRAY WITH WEDGE IS FOUND LOOSE AND REMOVED. IN SPITE OF THE WEDGE, THE TIBIAL COMPONENT LOOKS VARUS BUT WE CANNOT DETERMINE IF THIS IS THE POST-REVISION POSITION OR IT MOVED AFTER LOOSENING. IT LOOKS MORE LIKE A BONE FAILURE POSSIBLY CONSEQUENT TO THE FRACTURE. THE ATTEMPT BY THE SURGEON TO HAVE A RATHER CONSERVATIVE APPROACH DID NOT SUCCEED. NO REASON TO SUSPECT IMPLANT FAILURE.

    Description of Event or Problem · 1

    PATIENT CAME IN DUE TO PERSISTENT PAIN, SUSPECT MOBILIZATION OF THE TIBIAL TRAY HAS BEEN DIAGNOSED. THE SURGEON REVISED THE MOBILIZED TIBIAL TRAY, THE INSERT, THE EXTENSION STEM AND THE TIBIAL WEDGE ALMOST 1 YEAR AND 8 MONTHS AFTER PREVIOUS SURGERY. NO INFECTION HAS BEEN DETECTED. THE SURGERY WAS COMPLETED SUCCESSFULLY. WE WERE INFORMED ABOUT THE EVENT ON SEPTEMBER 2, THE REVISION HAS BEEN PERFORMED ON (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    947981 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 2 L TIBIAL TRAY FIXED CEMENTED JWH MEDACTA INTERNATIONAL SA 170413 07630030819865

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention