MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 L; KNEE CEMENTED FEMORAL COMPONENT

Model Number	02.12.0004L
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 23 march 2023: lot 180945: (b)(4) items manufactured and released on 03-may-2018.Expiration date: 2023-04-22.No anomalies found related to the problem.To date, all the items of the same lot have been sold without any similar reported event in the period of review.Additional implant involved: batch review performed on 23 march 2023 on gmk-sphere 02.12.T3i4l tibial tray fixed cemented size t3-i4 (k121416) l lot.180376.Lot 180376: (b)(4) items manufactured and released on 25-apr-2018.Expiration date: 2023-04-16.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.
Event or Problem Description
Revision surgery at about 4 years and 8 months post primary due to the cemented femur and tibia devices loosening.All devices were swapped successfully.Granulomas were present in the joint.
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs director: 5 years after primary cemented tka the components mobilize and require revision surgery.The report does not mention a traumatic event, although the massive mobilization of the tibial component and the contemporary mobilization of the femur lead to suspect that some triggering episode may have happened.However, this case should be categorized as aseptic loosening and we see no reason to suspect a defective or malfunctioning device as the main responsible.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 L
• Common Device Name: KNEE CEMENTED FEMORAL COMPONENT
• 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: 16743198
• Report Number: 3005180920-2023-00257
• Device Sequence Number: 5435036
• Product Code: JWH
• UDI-Device Identifier: 07630030825835
• UDI-Public: 07630030825835
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2023

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: 04/22/2023
• Device Model Number: 02.12.0004L
• Device Catalogue Number: 02.12.0004L
• Device Lot Number: 180945
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2023
• Supplement Date Received by Manufacturer: 03/17/2023
• Initial Report FDA Received Date: 04/14/2023
• Supplement Report FDA Received Date: 05/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/03/2018
• 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: 76 YR
• Patient Sex: Female