MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 3 R; KNEE TIBIAL TRAY CEMENTED

Model Number	02.07.1203R
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/12/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Aseptic loosening of a gmk sphere system 1 year 10 months after the primary.During the revision it was noted that the tibial component and the femoral component were loose and had no cement.The surgeon revised successfully all components.
Additional Manufacturer Narrative
Batch review performed on 28 july 2022: lot 1909605: 52 items manufactured and released on 29-apr-2020.Expiration date: 2025-04-20.No anomalies found related to the problem.To date, 51 items of the same lot have been sold with another similar reported event during the period of review.Additional device involved batch review performed on 28 july 2022 gmk-sphere 02.12.0022r femoral component sphere cemented size 2+ r (k140826) lot 2003245: 60 items manufactured and released on 08-june-2020.Expiration date: 2025-05-28.No anomalies found related to the problem.To date, 56 items of the same lot have been sold without any similar reported event during the period of review.Visual inspection performed by medacta r&d knee project mananger: revision surgery of a cemented gmk gmk sphere implant after around 2 years from implantation due to tibial aseptic loosening.During revision surgery, it was discovered that also the femoral component was loose.From visual inspection of the removed femoral component sent back for investigation (tibia not available), we can notice that some cement still adheres to the postero-medial side of the component, close to the chamfer.Poor interdigitation between cement and implant can be related to multiple factors, most likely not implant related (such as cementation process, temperature, time, presence of fluids on the surfaces of cement interface).The lack of cement adhering to the device is not evidence of a faulty device.No other elements relevant to the event can be noted from visual inspection.Clinical evaluation performed by medacta medical affairs director: revision of a cemented tka at 2 years from index surgery.Both femoral and tibial components were found thoroughly detached from the cement mantle, which suggests that some incident happened during cementation process, such as an unexpected or unperceived delay in placing the cement over the metallic component, or, more unlikely, that the components were wet when cement was applied on them.We know that the above-mentioned factors are determinant in making cement interdigitation with the metal surface almost non-existing.The visual inspection did not reveal any defect in the component surface.

• Brand Name: GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 3 R
• Common Device Name: KNEE TIBIAL TRAY CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 15154691
• Report Number: 3005180920-2022-00591
• Device Sequence Number: 5234984
• Product Code: JWH
• UDI-Device Identifier: 07630030819896
• UDI-Public: 07630030819896
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• 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): 08/03/2022

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: 04/20/2025
• Device Model Number: 02.07.1203R
• Device Catalogue Number: 02.07.1203R
• Device Lot Number: 1909605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2022
• Initial Report FDA Received Date: 08/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/29/2020
• 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: 66 YR
• Patient Sex: Female