MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 2 L; FIXED CEMENTED TIBIAL TRAY

Model Number	02.07.1202L
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/25/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 29 march 2022.Lot 182878: (b)(4) items manufactured and released on 28-aug-2018.Expiration date: 2023-jul-26.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event.Additional implant involved: gmk-sphere 02.12.0002l femoral component sphere cemented size 2 l (k121416) lot.168710.Batch review performed on 29 march 2022.Lot 168710: (b)(4) items manufactured and released on 05-may-2017.Expiration date: 2022-apr-18.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event since 2018.Additional implant involved: gmk-sphere 02.12.0210fl tibial insert fixed sphere flex siez 2/10 mm l (k121416) lot.177381.Batch review performed on 31 march 2022.Lot 177381: (b)(4) items manufactured and released on 23-feb-2018.Expiration date: 2023-feb-07.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event.
Event or Problem Description
Revision surgery due to an infection in the knee about 2 years and 10 months after the primary surgery.The prosthesis was removed and antibiotics and a spacer were inserted.

• Brand Name: GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 2 L
• Common Device Name: FIXED CEMENTED TIBIAL TRAY
• 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: 14165807
• Report Number: 3005180920-2022-00286
• Device Sequence Number: 20074156
• Product Code: JWH
• UDI-Device Identifier: 07630030819865
• UDI-Public: 07630030819865
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• 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): 04/21/2022

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: 07/26/2023
• Device Model Number: 02.07.1202L
• Device Catalogue Number: 02.07.1202L
• Device Lot Number: 182878
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2022
• Initial Report FDA Received Date: 04/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/28/2018
• 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: 77 YR
• Patient Sex: Female
• Patient Weight: 70 KG
• Patient Race: White