MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION FIXED TIBIAL TRAY CEMENTED SIZE 5 L; KNEE CEMENTED TIBIAL TRAY

Model Number	02.07.0685L
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/26/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 07 october 2022: lot 2108265: (b)(4) items manufactured and released on 24-nov-2021.Expiration date: 2026-10-28.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Additional involved implants: batch review performed on 07 october 2022 on gmk-sphere 02.12.0512fl tibial insert fixed sphere flex size 5/12 mm l (k121416) lot.2108922: (b)(4) items manufactured and released on 05-oct-2021.Expiration date: 2026-09-02.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.
Event or Problem Description
The patient had a primary knee surgery on (b)(6) 2022.On (b)(6) 2022, the patient came in reporting pain due to a fractured tibia and the cause is unknown.The surgeon converted the patient from uni-compartmental to a total knee system.The surgery was completed successfully.Presently, on (b)(6) 2022, the patient came in reporting pain and swelling in the knee and the cause is unknown.The surgeon revised the tibial tray and insert.The surgery was completed successfully.

• Brand Name: GMK-REVISION FIXED TIBIAL TRAY CEMENTED SIZE 5 L
• Common Device Name: KNEE CEMENTED TIBIAL TRAY
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 15637253
• Report Number: 3005180920-2022-00784
• Device Sequence Number: 5715743
• Product Code: JWH
• UDI-Device Identifier: 07630030819407
• UDI-Public: 07630030819407
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K123721
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 02.07.0685L
• Device Catalogue Number: 02.07.0685L
• Device Lot Number: 2108265
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2022
• Initial Report FDA Received Date: 10/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/24/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown