MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3 R

Model Number	02.12.0003R
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 29 march 2023.Lot 2007021: 132 items manufactured and released on 21-oct-2020.Expiration date:2025-oct-08.No anomalies found related to the problem.To date, 128 items of the same lot have been sold with no similar reported event during the period of review.Clinical evaluation performed by medical affairs director: 2 years after primary cemented tka the patient feels anterioir knee pain and gets revised.The original implants are exchanged; no explanation was supplied.Looking at the radiographs, potential insufficient lateral coverage of the tibia can observed and a rather pronounced internal rotation of the femoral component.It was a valgus case and therefore more complicated from the technical point of view.No evident cause for the pain could be identified with the information at hand, but there is no reason to suspect a faulty device.Additional items involved in the event, batch review performed on 29 march 2023: gmk-sphere 02.12.0210fr tibial insert fixed sphere flex size 2/10 mm r (k121416) lot.2005205.Lot 2005205: (b)(4) items manufactured and released on 29-jul-2020.Expiration date:2025-jul-08.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Gmk-sphere 02.07.1202r tibial tray fixed cemented size 2 r (k090988) lot.2004704.Lot 2004704: (b)(4) items manufactured and released on 28-aug-2020.Expiration date:2025-aug-19.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.
Event or Problem Description
Knee revision surgery performed about 2 years and 2 months after the primary surgery.Anterior pain described by the patient and instability.No infection.No loosening of the implants.The surgeon revised all components and switch to revision system with extension stems and resurfaced patient's natural patella.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3 R
• Common Device Name: FEMORAL COMPONENT SPHERE CEMENTED
• 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: 16805596
• Report Number: 3005180920-2023-00277
• Device Sequence Number: 20616002
• Product Code: JWH
• UDI-Device Identifier: 07630030825828
• UDI-Public: 07630030825828
• 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: 2021
• 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): 04/25/2023

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 Expiration Date: 10/08/2025
• Device Model Number: 02.12.0003R
• Device Catalogue Number: 02.12.0003R
• Device Lot Number: 2007021
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2023
• Initial Report FDA Received Date: 04/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/21/2020
• 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: 59 YR
• Patient Sex: Female
• Patient Weight: 90 KG