MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK PRIMARY TOTAL KNEE SYSTEM; GMK-PRIMARY PATELLA RESURFACING S.3

Model Number	02.07.0035RP
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 4 years and 2 month after primary, the patient came in reporting anterior knee pain and the cause is unknown.The surgeon revised the patella and revised the surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 08-oct-2024: lot 2000631: (b)(4) items manufactured and released on 26-feb-2020.Expiration date: 2025-02-12.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.

• Brand Name: GMK PRIMARY TOTAL KNEE SYSTEM
• Common Device Name: GMK-PRIMARY PATELLA RESURFACING S.3
• 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: 20545101
• Report Number: 3005180920-2024-00880
• Device Sequence Number: 7459429
• Product Code: JWH
• UDI-Device Identifier: 07630030815768
• UDI-Public: 07630030815768
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/28/2024

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: 02/12/2025
• Device Model Number: 02.07.0035RP
• Device Lot Number: 2000631
• 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: 10/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/26/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 86 KG
• Patient Race: White