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

Model Number	02.12.T3I4L
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 2 years and 6 months after the primary surgery, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout, removed all implants and implanted permanent hardware.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 07-mar-2023: lot 1909440: (b)(4) items manufactured and released on 12-mar-2020.Expiration date: 2025-03-01.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.Additional devices involved: batch reviews performed on 07-mar-2023: gmk-sphere 02.12.0410fl tibial insert fixed sphere flex size 4/10 mm l (k121416) lot 1909420: (b)(4) items manufactured and released on 03-dec-2019.Expiration date: 2024-11-17.No anomalies found related to the problem.To date, all items of the same lot have been sold with other two similar reported case during the period of review.Gmk-sphere 02.12.0004l femoral component sphere cemented size 4 l (k121416) lot 1910650: (b)(4) items manufactured and released on 09-apr-2020.Expiration date: 2025-03-31.No anomalies found related to the problem.To date, (b)(4) 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 L
• Common Device Name: KNEE TIBIAL INSERT
• 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: 16596971
• Report Number: 3005180920-2023-00203
• Device Sequence Number: 5310622
• Product Code: JWH
• UDI-Device Identifier: 07630030827136
• UDI-Public: 07630030827136
• 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: 2020
• Device Explanted Year: 2023
• 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): 03/23/2023

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 Expiration Date: 03/01/2025
• Device Model Number: 02.12.T3I4L
• Device Catalogue Number: 02.12.T3I4L
• Device Lot Number: 1909440
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2023
• Initial Report FDA Received Date: 03/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/12/2020
• 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: Female