BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE REVISION FIXED TIBIAL TRAY CEMENTED SIZE 2 R

    MDR report key: 8914342 · Received August 21, 2019

    Report

    Report Number
    3005180920-2019-00695
    Event Type
    Injury
    Date Received
    August 21, 2019
    Date of Event
    July 29, 2019
    Report Date
    August 21, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819353
    PMA / PMN Number
    K123721
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON (B)(6) 2019: LOT 173077: 16 ITEMS MANUFACTURED AND RELEASED ON 09/07/2017. EXPIRATION DATE: 08/24/2022. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 12 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ADDITIONAL DEVICES INVOLVED: BATCH REVIEWS PERFORMED ON (B)(6) 2019: GMK-SPHERE 02.07.F11030 PRIMARY EXTENSION STEM Ø11MM / L 30 MM (K123721) LOT 182015: 140 ITEMS MANUFACTURED AND RELEASED ON 05/08/2018. EXPIRATION DATE: 04/23/2023. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 128 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. GMK-SPHERE 02.09.TA210 TIBIAL AUGMENTATION SIZE 2/10MM (K123721) LOT 157176: 18 ITEMS MANUFACTURED AND RELEASED ON 02/01/2016. EXPIRATION DATE: 01/21/2021. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 13 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. GMK-SPHERE 02.12.0214FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/14 MM R (K123721) LOT 170317: 30 ITEMS MANUFACTURED AND RELEASED ON 05/09/2017. EXPIRATION DATE: 04/22/2022. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 2 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. GMK-SPHERE 02.12.0003R FEMORAL COMPONENT SPHERE CEMENTED SIZE 3 R (K123721) LOT 162681: 60 ITEMS MANUFACTURED AND RELEASED ON 06/092016. EXPIRATION DATE: 05/22/2021. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 58 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. GMK-SPHERE 02.07.0034RP PATELLA RESURFACING SIZE 2 (K123721) LOT 176302: 120 ITEMS MANUFACTURED AND RELEASED ON 01/05/2018. EXPIRATION DATE: 12/13/2022. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 115 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2018. THE PATIENT SUBSEQUENTLY HAD A REVISION SURGERY ON (B)(6) 2019. THE PATIENT CAME IN COMPLAINING OF INSTABILITY AND THE SURGEON PERFORMED A POLY-SWAP. MDR 3005180920-2019-00047 WAS DONE. ON (B)(6) 2019, THE PATIENT CAME IN COMPLAINING OF INSTABILITY (1 YEAR AND 4 MONTHS AFTER PRIMARY SURGERY) AND MEDACTA INTERNATIONAL WAS INFORMED THE SAME DAY. THE SURGEON ON THE (B)(6) 2019 REVISED THE PATIENT AND PERFORMED A HINGED KNEE ARTHROPLASTY. ALL HARDWARE REVISED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712093 GMK-SPHERE REVISION FIXED TIBIAL TRAY CEMENTED SIZE 2 R KNEE CEMENTED TIBIAL TRAY JWH MEDACTA INTERNATIONAL SA 173077 07630030819353

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention