MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK PRIMARY TOTAL KNEE SYSTEM; GMK-REVISION TIBIAL INSERT PS FIXED SIZE 2/14MM

Model Number	02.07.0214PSF
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient came in due to signs of infection and the pathogen is unknown.About 2 months after the primary surgery, the surgeon removed medacta hardware and implanted an antibiotic spacer.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 10 october 2024: lot 2245222: 30 items manufactured and released on 09-mar-2023.Expiration date: 2028-feb-20.No anomalies found related to the problem.To date, 16 items of the same lot have been sold with no similar reported event during the period of review.Additional devices involved: batch review performed on 10 october 2024: gmk-revision 02.07.0682r revision fixed tibial tray cemented size 2 r (k123721) lot 2313892: 48 items manufactured and released on 14-nov-2023.Expiration date: 2028-oct-28.No anomalies found related to the problem.To date, 27 items of the same lot have been sold with no similar reported event during the period of review.Gmk-revision 02.07.2402r femur revision ps size 2 r lot.181228a (k102437) lot 181228a: 3 items manufactured and released on 20-sep-2023.Expiration date: 2028-sep-05.No anomalies found related to the problem.To date, 2 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-REVISION TIBIAL INSERT PS FIXED SIZE 2/14MM
• 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: 20545257
• Report Number: 3005180920-2024-00894
• Device Sequence Number: 7827971
• Product Code: JWH
• UDI-Device Identifier: 07630030816680
• UDI-Public: 07630030816680
• 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: 2024
• 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 Model Number: 02.07.0214PSF
• Device Lot Number: 2245222
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2024
• Initial Report FDA Received Date: 10/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/09/2023
• 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 Sex: Unknown