MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 L; KNEE CEMENTED TIBIAL TRAY

Catalog Number	02.12.T3I4L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	09/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 19 september 2023.Lot 2000398: 150 items manufactured and released on 26-feb-2020.Expiration date: 2025-02-10.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.Clinical evaluation performed by medical affairs department: 3 years after cemented tka on a very lightweight and rather young female patient, instability and anterior knee pain are developed.For this reason the surgeon decided to proceed to secondary resurfacing of the patella and to increase the insert thickness, in order to reestablish joint tension and improve stability.Both these reasons are to be attributed to disease progression (instability) or disease to a different joint (patello-femoral) and therefore there is no reason to suspect a faulty device.
Event or Problem Description
At about 2 years 10 months after the primary, revision surgery due to knee instability.The surgeon revised the liner (10 to 14mm) with patellar bone resurfacing.

• Brand Name: GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 L
• 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: 17867197
• Report Number: 3005180920-2023-00776
• Device Sequence Number: 7041928
• Product Code: JWH
• UDI-Device Identifier: 07630030827136
• UDI-Public: 07630030827136
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K121416
• 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): 10/04/2023

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: 02/10/2025
• Device Catalogue Number: 02.12.T3I4L
• Device Lot Number: 2000398
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2023
• Initial Report FDA Received Date: 10/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/26/2020
• 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: 61 YR
• Patient Sex: Female
• Patient Weight: 49 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White