MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/12 MM R; KNEE TIBIAL INSERT PE

Model Number	02.12.0412FR
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/10/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs department early infection after primary cemented tka requires removal of all components.No reason to suspect that the implanted devices played a role in causing this adverse event.Batch review performed on 17 may 2022 lot 2108907: (b)(4) items manufactured and released on 16-sep-2021.Expiration date: 2026-09-03.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Additional components involved: gmk-sphere 02.12.0004r femoral component sphere cemented size 4 r (k121416) lot.2102536: (b)(4) items manufactured and released on 28-apr-2021.Expiration date: 2026-04-18.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Gmk-sphere 02.07.1204r tibial tray fixed cemented size 4 r (k090988) lot.2108282: (b)(4) items manufactured and released on 12-oct-2021.Expiration date: 2026-09-24.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Gmk-primary 02.07.F11030 primary extension stem ø11mm / l 30 mm (k133630) lot.2105043: (b)(4) items manufactured and released on 13-july-2021.Expiration date: 2026-06-24.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.
Event or Problem Description
At about 3 months and a half after the primary, revision surgery was performed due to infection.The surgeon revised all components and the surgery was completed successfully.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/12 MM R
• Common Device Name: KNEE TIBIAL INSERT PE
• 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: 14641376
• Report Number: 3005180920-2022-00433
• Device Sequence Number: 20059852
• Product Code: JWH
• UDI-Device Identifier: 07630030826580
• UDI-Public: 07630030826580
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 06/09/2022

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: 09/03/2026
• Device Model Number: 02.12.0412FR
• Device Catalogue Number: 02.12.0412FR
• Device Lot Number: 2108907
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2022
• Initial Report FDA Received Date: 06/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/16/2021
• 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: 61 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White