MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK PRIMARY TOTAL KNEE SYSTEM; GMK-SPHERE PATELLA RESURFACING SIZE 4

Model Number	02.07.0036RP
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	12/27/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 30-dec-2024: lot 2242833: (b)(4) items manufactured and released on 03-jan-2023.Expiration date: 2027-12-12.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.Batch reviews performed on 30-dec-2024: gmk-sphere 02.07.1204l tibial tray fixed cemented size 4 l (k090988) lot 2207305: (b)(4) items manufactured and released on 26-jul-2022.Expiration date: 2027-07-12.No anomalies found related to the problem.To date, all the items of the same lot have been sold with no similar reported event during the period of review.Gmk-sphere 02.12.0024l femoral component sphere cemented size 4+ l (k140826) lot 2245092: (b)(4) items manufactured and released on 08-feb-2023.Expiration date: 2028-01-25.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.Gmk-sphere 02.12.0410fl tibial insert fixed sphere flex size 4/10 mm l (k121416) lot 2304911: (b)(4) items manufactured and released on 21-apr-2023.Expiration date: 2028-04-09.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.Root cause: there is no indication that any potential issue with the device may have caused or contributed to the event, and the device history record review does not indicate any potential manufacturing related issue.
Event or Problem Description
At about 1 year and 4 months after primary, the patient came in reporting instability.It was not possible to achieve the correct balance of the knee in both flexion and extension.The surgeon revised all components to competitor components and the surgery was completed successfully.

• Brand Name: GMK PRIMARY TOTAL KNEE SYSTEM
• Common Device Name: GMK-SPHERE PATELLA RESURFACING SIZE 4
• 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: 21197088
• Report Number: 3005180920-2024-01172
• Device Sequence Number: 12631407
• Product Code: JWH
• UDI-Device Identifier: 07630030815775
• UDI-Public: 07630030815775
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K113571
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 01/21/2025

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: 02.07.0036RP
• Device Lot Number: 2242833
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2024
• Initial Report FDA Received Date: 01/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/03/2023
• 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: Male