MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERETIBIAL TRAY FIXED CEMENTED SIZE 4 R; KNEE CEMENTED TIBIAL TRAY

Catalog Number	02.07.1204R
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	12/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 3 years and 2 months from the primary, revision surgery due to tibial and femoral components loosening.During the surgery, it was observed that there was no cement on both components and the liner seems to be delaminated.
Additional Manufacturer Narrative
Batch review performed on 14 december 2023.Lot 1907840: (b)(4) items manufactured and released on 03-mar-2020.Expiration date: 2025-02-16.No anomalies found related to the problem.To date, all 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 14 december 2023.Gmk-sphere 02.12.0005r femoral component sphere cemented size 5 r () lot 1910668: (b)(4) items manufactured and released on 16-mar-2020.Expiration date: 2025-06-06.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.Visual inspection performed by medacta r&d knee project manager: revision surgery of a gmk sphere implant after 3 year and 2 moths from primary due to tibia and femoral loosening.From visual inspection of the removed components sent bask for investigation, no residual cement can be noted on the distal surface of tibial baseplate and on the internal surfaces of the femoral component.Some halos is also noticeable, most likely due to the washing process.The articular surfaces of the tibial insert present some dents and small craters, like if a third body (like cement) was interposed.Articular surfaces of the femoral component is not damaged.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).Absence of cement, is not an evidence of a faulty device.From preliminary investigation, there is no evidence that the event is related to a faulty device.Clinical evaluation performed by medacta medical affairs director: 3 years after primary cemented tka, both components get loose and need replacement.According to radiographs and pictures, a cementation problem can be suspected: the metal parts appear to be detached from cement, and no residual cement was visible on either explanted component.This type of phenomenon may happen when, for instance, cement application is delayed, but of course we cannot state that this is the ascertained cause of this case.However, we see no reason to suspect a faulty implant.

• Brand Name: GMK-SPHERETIBIAL TRAY FIXED CEMENTED SIZE 4 R
• Common Device Name: KNEE CEMENTED TIBIAL TRAY
• 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: 18451505
• Report Number: 3005180920-2023-01051
• Device Sequence Number: 20724611
• Product Code: JWH
• UDI-Device Identifier: 07630030819919
• UDI-Public: 07630030819919
• 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: 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
• Report Date (Section B): 01/05/2024

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: 02/16/2025
• Device Catalogue Number: 02.07.1204R
• Device Lot Number: 1907840
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2023
• Initial Report FDA Received Date: 01/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2020
• 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: 58 YR
• Patient Sex: Female