MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 2 R; KNEE TIBIAL TRAY

Catalog Number	02.07.1202R
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 22 february 2024.Lot 1907825: (b)(4) items manufactured and released on 08-jan-2020.Expiration date: 2024-12-14.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.
Event or Problem Description
At about 3 years 8 months after the primary, revision surgery performed for tibial tray subsidence.A semi-constraint (gmk revision) was successfully implanted.
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs department: 4 years after cemented primary tka, the patient is in pain and the surgeon finds, according to the report, a mobilized tibial component.So they decided to exchange the existing device with a semi-constrained system.The explanted devices have no trace of residual cement on the metal surfaces, which leads us to suspect that a problem with cementation took place during index surgery.Additionally, although we had some troubles assigning the radiographs to the correct time point, it appears that the femoral component may have mobilized too - if not, a potential problem with external rotation was probably present, but we cannot tell if it was there since the beginning or if it is the result of progressive mobilization.Also, it is unclear, with the information at hand, how the untreated components of the knee joint degenrated over the four years since primary surgery: this could help us understand the choice of going from a rather conservative initial treatment to a quite aggressive revision device with elaborated stem and offset options.Visual inspection perforemd by r&d project manager from visual inspection no anomalies can be noted on the explanted components.No residual cement can be identifed on the distal surface of tibial baseplate and on the internal surface of the femoral component.Poor interdigitation between cement and implant can be related to multiple factors, not implant related (such as cementation process, temperature, time, presence of fluids on the surfaces of cement interface).On the articular surfaces of the tibial insert, no signs of wear or delamination can be noted.From visual inspection, there is no evidence to suspect that the event is related to a faulty device.Information reported in the follow up: - clinical evaluation - visual inspection - piece returned on 03/13/2024.

• Brand Name: GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 2 R
• Common Device Name: KNEE 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: 18805802
• Report Number: 3005180920-2024-00084
• Device Sequence Number: 12570481
• Product Code: JWH
• UDI-Device Identifier: 07630030819872
• UDI-Public: 07630030819872
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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,Followup
• Report Date (Section B): 04/12/2024

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: 12/14/2024
• Device Catalogue Number: 02.07.1202R
• Device Lot Number: 1907825
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2024
• Supplement Date Received by Manufacturer: 01/31/2024
• Initial Report FDA Received Date: 02/29/2024
• Supplement Report FDA Received Date: 04/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2020
• 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: 75 YR
• Patient Sex: Male
• Patient Weight: 63 KG
• Patient Ethnicity: Hispanic