BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/17MM

    MDR report key: 9086485 · Received September 19, 2019

    Report

    Report Number
    3005180920-2019-00782
    Event Type
    Injury
    Date Received
    September 19, 2019
    Date of Event
    August 21, 2019
    Report Date
    September 19, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030817991
    PMA / PMN Number
    K103170
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 2 SEPTEMBER 2019: LOT 162518: (B)(4) ITEMS MANUFACTURED AND RELEASED ON "22-AGO-2016". EXPIRATION DATE: 2021-07-26. 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 IN THE COMPLAINT. GMK-REVISION 02.07.0684R REVISION FIXED TIBIAL TRAY CEMENTED SIZE 4 R LOT. 164180 (K123721). BATCH REVIEW PERFORMED ON 2 SEPTEMBER 2019: LOT 164180: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-SEP-2016. EXPIRATION DATE: 2021-09-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ANOTHER SIMILAR EVENT REPORTED. GMK-REVISION 02.07.2405R FEMUR REVISION PS SIZE 5 R LOT. 171336 (K102437). BATCH REVIEW PERFORMED ON 2 SEPTEMBER 2019: LOT 171336: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-JUN-2017. EXPIRATION DATE: 2022-05-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ANOTHER SIMILAR EVENT REPORTED. GMK-REVISION 02.07.FCL18105 EXTENSION STEM - FLUTED Ø 18 L 105 LOT. 172187 (K120790). BATCH REVIEW PERFORMED ON 2 SEPTEMBER 2019: LOT 172187: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-JUL-2017. EXPIRATION DATE: 2022-07-02. 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. GMK-REVISION 02.07.0003 OFFSET CONNECTOR 3 MM LOT. 178518 (K102437). BATCH REVIEW PERFORMED ON 2 SEPTEMBER 2019: LOT 178518: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-MAR-2018. EXPIRATION DATE: 2023-02-27. 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. GMK-REVISION 02.07.FCL13105 EXTENSION STEM - FLUTED Ø 13 L 105 LOT. 160040 (K120790). BATCH REVIEW PERFORMED ON 2 SEPTEMBER 2019: LOT 160040: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-APR-2016. EXPIRATION DATE: 2021-03-29. 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. GMK-REVISION 02.09.TA410 TIBIAL AUGMENTATION SIZE 4/10MM LOT. 123246B (K130299). BATCH REVIEW PERFORMED ON 2 SEPTEMBER 2019: LOT 123246B: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-APR-2018. EXPIRATION DATE: 2023-03-25. 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. 2 DEVICES OF THIS LOT INVOLVED IN THIS COMPLAINT.

    Description of Event or Problem · 1

    THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2018. THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN WAS UNKNOWN. THE SURGEON SUBSEQUENTLY PERFORMED AN I&D AND POLY SWAP ON (B)(6) 2019 AND COMPLAINT (B)(4) WAS FILED. PRESENTLY 9 MONTHS AFTER PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL IMPLANTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    884904 GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/17MM FIXED TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 162518 07630030817991

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention