MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE 02.12.0007L FEMORAL COMPONENT SPHERE CEMENTED SIZE 7 L

Model Number	02.12.0007L
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/18/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 15-mar-2022.Lot 2001642: (b)(4) items manufactured and released on 24-jun-2020.Expiration date: 2025-06-15.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Clinical evaluation performed by medical affairs manager: second revision in cemented tka in a (b)(6) patient.After 1 year from the primary surgery a first revision was necessary due to a delayed infection: the tibial implant was removed.However, after few months from the first revision a second revision occured due to the same problem.Therefore, all implants were removed and a spacer was inserted.Infection is a known possible adverse event following every surgery, including tka's.To date, there is no reason to suspect that the cause may be linked to the implanted devices.Other devices involved: batch review performed on 15-mar-2022.Gmk-sphere 02.07.1206l tibial tray fixed cemented # 6 l (k090988) lot 2002938: (b)(4) items manufactured and released on 24-jun-2020.Expiration date: 2025-06-15.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 02.12.0614fl tibial insert fixed sphere flex #6/14 mm (k121416) lot 183035: (b)(4) items manufactured and released on 10-jul-2018.Expiration date: 2023-06-24.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Gmk-sphere 02.12.0614fl tibial insert fixed sphere flex #6/14 mm l (k121416) lot 156319: (b)(4) items manufactured and released on 04-apr-2016.Expiration date: 2021-03-21.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event since 2018.
Event or Problem Description
The patient had the primary surgery on (b)(6) 2020, the first revision surgery was performed on (b)(6) 2021 due to infection, the tibial insert was replaced.On (b)(6) 2022 the insert, femur, and tibia were replaced due to infection again.

• Brand Name: GMK-SPHERE 02.12.0007L FEMORAL COMPONENT SPHERE CEMENTED SIZE 7 L
• Common Device Name: FEMORAL COMPONENT
• 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: 13826326
• Report Number: 3005180920-2022-00188
• Device Sequence Number: 1000020
• Product Code: JWH
• UDI-Device Identifier: 07630030825897
• UDI-Public: 07630030825897
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/18/2022

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: 06/15/2025
• Device Model Number: 02.12.0007L
• Device Catalogue Number: 02.12.0007L
• Device Lot Number: 2001642
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2022
• Initial Report FDA Received Date: 03/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/24/2020
• 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 Age: 65 YR
• Patient Sex: Male
• Patient Weight: 86 KG