MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE 02.12.0005L FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 L

Model Number	02.12.0005L
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 22 october 2021: lot 1810101: (b)(4) items manufactured and released on 20-feb-2019.Expiration date: 2024-feb-10.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by medical affairs manager: delayed infection in cemented tka, 1 year after primary operation.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 22 october 2021: gmk-sphere 02.12.0510fl tibial insert fixed sphere flex #5/10 mm l (k121416) lot 189013: (b)(4) items manufactured and released on 20-feb-2019.Expiration date: 2024-feb-07.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with one similar reported event.Gmk-sphere 02.07.1205l tibial tray fixed cemented # 5 l (k090988) lot 1910497: (b)(4) items manufactured and released on 24-mar-2020.Expiration date: 2025-mar-15.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with no similar reported event.Gmk-sphere 02.07.0035rp patella resurfacing # 3 (k090988) lot 1905310: (b)(4) items manufactured and released on 09-aug-2019.Expiration date: 2024-jul-27.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with no similar reported event.
Event or Problem Description
Left knee revision surgery due to infection was performed 1 year after the primary surgery.Hinge system implanted.

• Brand Name: GMK-SPHERE 02.12.0005L FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 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: 12758076
• Report Number: 3005180920-2021-00850
• Device Sequence Number: 3310292
• Product Code: JWH
• UDI-Device Identifier: 07630030825859
• UDI-Public: 07630030825859
• 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: 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): 11/05/2021

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: 02/10/2024
• Device Model Number: 02.12.0005L
• Device Catalogue Number: 02.12.0005L
• Device Lot Number: 1810101
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2021
• Initial Report FDA Received Date: 11/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/20/2019
• 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: Other
• Patient Age: 67 YR
• Patient Sex: Male