MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK SPHERE TOTAL KNEE SYSTEM; KNEE FEMORAL COMPONENT

Model Number	02.12.0004L
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	09/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient undergone primary surgery on the (b)(6) 2020 and gmk-sphere components, without patella resurfacing, have been implanted.On the (b)(6) 2022, the patient has been revised because of anterior knee pain and loosening of the tibial tray.The surgeon revised successfully the tibial tray and insert and implanted a resurfacing patella size 1.Presently, on the (b)(6) 2024, the patient has been revised due to pain.No loosening and infection detected.The surgeon removed femoral and tibial components and insert and implanted gmk-revision system.
Additional Manufacturer Narrative
Batch review performed on 19-sep-2024.Lot 1910650: (b)(4) items manufactured and released on 09-apr-2020.Expiration date: 2025-03-21.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.Clinical evaluation performed by medical affairs director: 4 years after revision tka, the patient complains of knee pain and a new revision is undertaken.No further information is available.The quality of the images supplied is such that no comment can be made from them.The report does not mention any problem with the implants, and in fact it says explicitly that no infection and no loosening were detected.Other devices involved: gmk-sphere tibial insert fixed sphere flex size 4/10 mm l (k121416) lot 2112453: (b)(4) items manufactured and released on 04-nov-2021.Expiration date: 2026-10-12.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 tibial tray fixed cemented size t3i4 l (k121416) lot 2112049: (b)(4) items manufactured and released on 14-dec-2021.Expiration date: 2026-11-25.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.

• Brand Name: GMK SPHERE TOTAL KNEE SYSTEM
• Common Device Name: KNEE 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: 20426111
• Report Number: 3005180920-2024-00807
• Device Sequence Number: 7608744
• Product Code: JWH
• UDI-Device Identifier: 07630030825835
• UDI-Public: 07630030825835
• 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: 2024
• 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): 10/11/2024

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: 03/21/2025
• Device Model Number: 02.12.0004L
• Device Lot Number: 1910650
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2024
• Initial Report FDA Received Date: 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/09/2020
• 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: 71 YR
• Patient Sex: Female
• Patient Weight: 70 KG