MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK SPHERE TOTAL KNEE SYSTEM; GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 7 R

Model Number	02.12.0007R
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
At about 5 months after primary, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and revised the femoral component and insert.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 07-oct-2024: lot 2312312: (b)(4) items manufactured and released on 13-sep-2023.Expiration date: 2028-08-21.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.Additional device involved: batch review performed on 07-oct-2024: gmk-sphere 02.12.E0612fr tibial insert fixed sphere flex #6/12 mm r e-cross (k202022) lot 2002537: (b)(4) items manufactured and released on 20-jul-2020.Expiration date: 2025-07-03.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: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 7 R
• 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: 20545290
• Report Number: 3005180920-2024-00876
• Device Sequence Number: 7817074
• Product Code: JWH
• UDI-Device Identifier: 07630030825903
• UDI-Public: 07630030825903
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K121416
• 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: Company Representative
• 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: 02.12.0007R
• Device Lot Number: 2312312
• 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: 09/13/2023
• 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