MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK SPHERE TOTAL KNEE SYSTEM; FEMORAL COMPONENT SPHERE CEMENTED SIZE 1 L

Model Number	02.12.0001L
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	09/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision due to tibial and femoral components loosening, 8 years after primary.All components successfully revised using gmk-hinge implants.
Additional Manufacturer Narrative
Batch review performed on 23 september 2024.Lot 162649: (b)(6) items manufactured and released on 19-may-2016.Expiration date: 2021-05-16.No anomalies found related to the problem.To date, (b)(6) items of the same lot have been sold without any similar reported event during the period of review.Clinical evaluation performed by medical affairs director.8 years after primary cemented tka on an elderly lady with extreme varus knees, the components mobilize and require exchange to a constrained system.The radiographs supplied, presumably taken right before revision, show a significant medial osteophyte of the distal femur, which must have been articulating for a long time against the pe insert, causing damages and possibly contributing to the mobilization.Clearly this adverse event cannot be ascribed to a defect or malfunction of the implanted devices.Additional implant involved, batch review performed on 23 september 2024.Gmk-sphere 02.07.1202l tibial tray fixed cemented size 2 l (k090988) lot 164086: (b)(6) items manufactured and released on 08-sep-2016.Expiration date: 2021-08-30.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported event during the period of review.

• Brand Name: GMK SPHERE TOTAL KNEE SYSTEM
• Common Device Name: FEMORAL COMPONENT SPHERE CEMENTED SIZE 1 L
• 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: 20460596
• Report Number: 3005180920-2024-00818
• Device Sequence Number: 15402257
• Product Code: JWH
• UDI-Device Identifier: 07630030825774
• UDI-Public: 07630030825774
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 10/16/2024

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: 05/16/2021
• Device Model Number: 02.12.0001L
• Device Lot Number: 162649
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2024
• Initial Report FDA Received Date: 10/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/19/2016
• 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: 84 YR
• Patient Sex: Female
• Patient Weight: 52 KG