MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK SPHERE TOTAL KNEE SYSTEM; FEMORAL COMPONENT SPHERE CEMENTED SIZE 4R

Model Number	02.12.0004R
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	07/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 2 year and 4 months form the primary surgery, the patient underwent revision surgery due to loosening of all components.No infection detected.The surgery was concluded successfully.
Additional Manufacturer Narrative
Batch review performed on 11-jul-2025, gmk-sphere 02.12.0004r femoral component sphere cemented size 4 r (k121416) lot.2247628: (b)(4) items manufactured and released on 23-feb-2023.Expiration date: 08-feb-2028.No anomalies found related to the problem.To date, 71 items of the same lot have been sold with no similar reported event during the period of review.Additional items involved in the event, batch review performed on 11-jul-2025: gmk-sphere 02.07.1204r tibial tray fix cemented s.4r (k090988) lot.2245181: (b)(4) items manufactured and released on 07-mar-2023.Expiration date: 16-feb-2028.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.Clinical evaluation performed by medical affairs department: 2 years after primary tka, mobilization of all components occurs.The position of the implants seems to be suboptimal, even though with the short xrays we cannot tell definitely.In the sagittal plane, anyway, the slope chosen at the time of index surgery appears very peculiar and we have no information as to the reasons that may have led the surgeon to choose this option.Root cause: based on the information available no definitive root cause can be established, while 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.

• Brand Name: GMK SPHERE TOTAL KNEE SYSTEM
• Common Device Name: FEMORAL COMPONENT SPHERE CEMENTED SIZE 4R
• 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: 22541064
• Report Number: 3005180920-2025-00698
• Device Sequence Number: 15211122
• Product Code: JWH
• UDI-Device Identifier: 07630030825842
• UDI-Public: 07630030825842
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/18/2025

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: 02.12.0004R
• Device Lot Number: 2247628
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2025
• Initial Report FDA Received Date: 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/23/2023
• 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: 70 YR
• Patient Sex: Male