MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERIKA 02.07.1204L TIBIAL TRAY FIX CEMENTED S.4L; KNEE TIBIAL TRAY FIX CEMENTED

Catalog Number	02.07.1204L
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/12/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2023.Lot 2237762: (b)(4) items manufactured and released on 06-dec-2022.Expiration date: 2027-11-22.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.Other devices involved: gmk-spherika 02.12.0411fl gmk-sphere tibial insert - flex s4l - 11 mm (k140826) lot 2112458: (b)(4)items manufactured and released on 14-oct-2021.Expiration date: 2026-09-29.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with another similar reported case during the period of review.Gmk-spherika 02.12.Ka05l gmk spherika femoral component s5l cemented (k211004) lot 2112573: (b)(4) items manufactured and released on 3-nov-2021.Expiration date: 2026-10-20.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.
Event or Problem Description
At about 8 months from the primary, the patient came in due to signs of infection and the pathogen is unknown.The surgeon revised all medacta hardware and re-implanted permanent components.The surgery was completed successfully.

• Brand Name: GMK-SPHERIKA 02.07.1204L TIBIAL TRAY FIX CEMENTED S.4L
• Common Device Name: KNEE TIBIAL TRAY FIX CEMENTED
• 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: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 18111193
• Report Number: 3005180920-2023-00862
• Device Sequence Number: 20806078
• Product Code: JWH
• UDI-Device Identifier: 07630030819902
• UDI-Public: 07630030819902
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 11/10/2023

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 Catalogue Number: 02.07.1204L
• Device Lot Number: 2237762
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2023
• Initial Report FDA Received Date: 11/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/06/2022
• 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: Male