MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 2+ L

Model Number	02.12.0022L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery for knee infection at about 10 months from primary surgery.All devices were revised successfully.
Additional Manufacturer Narrative
Batch review performed on 07 march 2023: lot 2112914: (b)(4) manufactured and released on 06-dec-2021.Expiration date: 2026-11-22.No anomalies found related to the problem.To date, (b)(4).Of the same lot have been sold without any similar reported event in the period of review.Clinical evaluation performed by medical affairs department: early infection in a tka, 10 months after primary surgery.All devices were revised successfully.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.Additional items involved in the event, batch review performed on 07 march 2023: gmk-sphere 02.12.0311crl tibial insert fixed sphere cr size 3/11 mm l (k181635) lot.2110326 lot 2110326: (b)(4) manufactured and released on 16-sep-2021.Expiration date: 2026-09-01.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold without any similar reported event in the period of review.Gmk-sphere 02.07.1203l tibial tray fixed cemented size 3 l (k090988) lot.2114756 lot 2114756: (b)(4) manufactured and released on 08-feb-2022.Expiration date: 2027-01-26.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold without any similar reported event in the period of review.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 2+ L
• Common Device Name: FEMORAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 16618608
• Report Number: 3005180920-2023-00189
• Device Sequence Number: 20374703
• Product Code: JWH
• UDI-Device Identifier: 07630030862472
• UDI-Public: 07630030862472
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K140826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• 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): 03/27/2023

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 Model Number: 02.12.0022L
• Device Catalogue Number: 02.12.0022L
• Device Lot Number: 2112914
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2023
• Initial Report FDA Received Date: 03/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/06/2021
• 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: 87 YR
• Patient Sex: Female