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

Catalog Number	02.07.1205R
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	03/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 2 months after the primary, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon removed all components and implanted an antibiotic spacer.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2024: lot 2315167: 24 items manufactured and released on (b)(6) 2023.Expiration date: 2028-09-17.No anomalies found related to the problem.To date, 23 items of the same lot have been sold without any similar reported event during the period of review.Additional implants involved, batch review performed on (b)(6) 2024: gmk-spherika 02.12.E0513fr tibial insert fixed sphere flex size 5/13 mm r e-cross (k202022) lot 2242963: 25 items manufactured and released on 03-jan-2023.Expiration date: 2027-12-06.No anomalies found related to the problem.To date, 11 items of the same lot have been sold without any similar reported event during the period of review.Gmk-spherika 02.12.Ka05r femoral component spherika cemented s5r (k211004) lot 2340179: 15 items manufactured and released on (b)(6) 2023.Expiration date: 2028-11-13.No anomalies found related to the problem.To date, 7 items of the same lot have been sold without any similar reported event during the period of review.
Additional Manufacturer Narrative
The patient came in on (b)(6) 2024 and had permanent hardware implanted.

• Brand Name: GMK-SPHERIKA TIBIAL TRAY FIXED CEMENTED SIZE 5 R
• Common Device Name: KNEE 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: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 19178698
• Report Number: 3005180920-2024-00267
• Device Sequence Number: 20685895
• Product Code: JWH
• UDI-Device Identifier: 07630030819933
• UDI-Public: 07630030819933
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2024

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: 02.07.1205R
• Device Lot Number: 2315167
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/25/2024
• Supplement Report FDA Received Date: 07/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/04/2023
• 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