MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 6+ R; KNEE CEMENTED FEMUR

Model Number	02.12.0026R
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 30 june 2021: lot 163349: (b)(4) items manufactured and released on 26-jun-2016.Expiration date: 2021-06-19.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without other similar reported events since 2017.Additional device involved: batch reviews performed on 30 june 2021: gmk-sphere 02.07.1205r tibial tray fixed cemented size 5 r (k090988) lot 187304: (b)(4) items manufactured and released on 03-jan-2019.Expiration date: 2023-12-12.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without other similar reported events.Gmk-sphere 02.12.0511fr tibial insert fixed sphere flex size 5/11 mm r (k140826) lot 1904565: (b)(4) items manufactured and released on 15-jul-2019.Expiration date: 2024-07-01.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without other similar reported events.Gmk-sphere 02.07.0035rp patella resurfacing size 3 (k090988) lot 1811665: (b)(4) items manufactured and released on 29-mar-2019.Expiration date: 2024-03-16.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without other similar reported events.Clinical evaluation performed by medacta medical affairs manager: recurrent infection in cemented tka.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.
Event or Problem Description
The surgeon revised all implants on (b)(6) 2021 due to infection and installed a cement spacer.On (b)(6) 2021 the surgeon removed the cement spacer and installed new implants.The primary surgery was performed on (b)(6) 2019.The patient had previously ((b)(6) 2020) a liner revision and washout also due to infection.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 6+ R
• Common Device Name: KNEE CEMENTED FEMUR
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12157568
• Report Number: 3005180920-2021-00583
• Device Sequence Number: 19987627
• Product Code: JWH
• UDI-Device Identifier: 07630030862441
• UDI-Public: 07630030862441
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K140826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• 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): 07/13/2021

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: 06/19/2021
• Device Model Number: 02.12.0026R
• Device Catalogue Number: 02.12.0026R
• Device Lot Number: 163349
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2021
• Initial Report FDA Received Date: 07/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Weight: 90