MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK SPHERE TOTAL KNEE SYSTEM; GMK-SPHERE SPHERE FEMUR CEMENTED LEFT S5 +

Model Number	02.12.0025L
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/30/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 07-oct-2024: lot 2001675: (b)(4) items manufactured and released on 18-jun-2020.Expiration date: 2025-06-08.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 02.07.1204l tibial tray fixed cemented size 4 l (k090988) lot 2002931: (b)(4) items manufactured and released on 15-jul-2020.Expiration date: 2025-07-07.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.
Event or Problem Description
At about 2 years after the primary, the patient has been revised because of femoral and tibial components mobilization.It was reported that the patient started to experience problems immediately after the primary.During the revision, the femoral implant came off immediately and a little amount of cement remained on the condyle of the device.All implants have been revised successfully.

• Brand Name: GMK SPHERE TOTAL KNEE SYSTEM
• Common Device Name: GMK-SPHERE SPHERE FEMUR CEMENTED LEFT S5 +
• 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: 20545183
• Report Number: 3005180920-2024-00873
• Device Sequence Number: 20697987
• Product Code: JWH
• UDI-Device Identifier: 07630030862410
• UDI-Public: 07630030862410
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K140826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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 Expiration Date: 06/08/2025
• Device Model Number: 02.12.0025L
• Device Lot Number: 2001675
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2024
• Initial Report FDA Received Date: 10/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/18/2020
• 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
• Patient Race: White