MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 R; KNEE TIBIAL TRAY CEMENTED

Model Number	02.12.T3I4R
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/23/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 1 year from the primary surgery, the patient came in due to signs of infection and the pathogen is unknown.The surgeon performed a washout and revised the femoral component, tibial tray and insert.The new implants will be used as a temporary antibiotic spacer and the patient will have permanent hardware implanted at a later date.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2022: lot 1904614: 73 items manufactured and released on 08-oct-2019.Expiration date: 2024-09-25.No anomalies found related to the problem.To date, all items of the same lot have been sold with no other similar reported case during the period of review.Additional devices involved: batch reviews performed on (b)(6) 2022: gmk-sphere 02.12.0411fr tibial insert fixed sphere flex size 4/11 mm r (k140826) lot 176179: 25 items manufactured and released on 17-jan-2018.Expiration date: 2023-01-07.No anomalies found related to the problem.To date, 24 items of the same lot have been sold with no other similar reported case during the period of review.Gmk-sphere 02.12.0004r femoral component sphere cemented size 4 r (k121416) lot 1907917: 104 items manufactured and released on 11-nov-2019.Expiration date: 2024-10-27.No anomalies found related to the problem.To date, 100 items of the same lot have been sold with no other similar reported case during the period of review.

• Brand Name: GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 R
• Common Device Name: KNEE TIBIAL TRAY CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 15040376
• Report Number: 3005180920-2022-00545
• Device Sequence Number: 14714872
• Product Code: JWH
• UDI-Device Identifier: 07630030827143
• UDI-Public: 07630030827143
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/18/2022

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 Expiration Date: 09/25/2024
• Device Model Number: 02.12.T3I4R
• Device Catalogue Number: 02.12.T3I4R
• Device Lot Number: 1904614
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2022
• Initial Report FDA Received Date: 07/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/08/2019
• 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 Age: 52 YR
• Patient Sex: Female