MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK PRIMARY TOTAL KNEE SYSTEM; KNEE PATELLA RESURFACING IMPLANT

Model Number	02.07.0035RP
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	10/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 11-oct-2024.Lot: 2112779: (b)(4) items manufactured and released on 15-dec-2021.Expiration date: 2026-11-28.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 clinical affairs department about 2.5 years after revision of patella resurfacing consequent to a traumatic event, the patella is found painful again and a new revision is undertaken.The tibiofemoral implants are still working satisfactorily, replacement of the tibial insert is carried out as standard precautionary measure.The resurfacing patella is exchanged again but the most important action taken by the surgeon is the uplifting of the anterior tibial tuberosity, which in his opinion could solve the problem.No reason to suspect a faulty device at the origin of this revision.
Event or Problem Description
The patient had a primary surgery on (b)(6) april 2015.Gmk-sphere femur, tibia and insert implanted.On (b)(6) 2016, the patient has been revised (complementary surgery) and patella implant size 3 has been implanted.On (b)(6) 2022, the patient came in reporting pain and undergone a revision surgery because of a falling on (b)(6) 2021 with subsequent loosening of the patella implant.No loosening of the other components or infection.Implantation of a new patella implant size 3.Presently, on (b)(6) 2024, the patient came in reporting anterior knee pain and it was suspected loosening of patella implant.Resurfacing of patella size 3 and implantation of a new size 3.No loosening of the components detected.Changing of the tibial insert was done as preventive measure.Moreover, the surgeon decided to raise the anterior tibial tuberosity because the patella was very low and this could explain the pain, according to the surgeon opinion.

• Brand Name: GMK PRIMARY TOTAL KNEE SYSTEM
• Common Device Name: KNEE PATELLA RESURFACING IMPLANT
• 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: 20557968
• Report Number: 3005180920-2024-00898
• Device Sequence Number: 11538957
• Product Code: JWH
• UDI-Device Identifier: 07630030815768
• UDI-Public: 07630030815768
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 10/29/2024

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 Model Number: 02.07.0035RP
• Device Lot Number: 2112779
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2024
• Initial Report FDA Received Date: 10/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/15/2021
• 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: 79 YR
• Patient Sex: Female
• Patient Weight: 113 KG