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

Catalog Number 02.07.1205R

Device Problem Device Appears to Trigger Rejection (1524)

Event Date 03/29/2024

Event Type  Injury  

Event 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.

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.

• Brand Name: GMK-SPHERIKA TIBIAL TRAY FIXED CEMENTED SIZE 5 R
• Type of Device: 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
• MDR Text Key: 341001219
• Report Number: 3005180920-2024-00267
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 07630030819933
• UDI-Public: 07630030819933
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090988
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/25/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 02.07.1205R
• Device Lot Number: 2315167
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/29/2024
• Initial Date FDA Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/04/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention