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

Catalog Number	02.12.T3I4R
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 1 year from the primary, the patient came in reporting anterior pain due to loosening of the tibial tray.The surgeon revised the tibial tray and resurfaced the natural patella.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 08 january 2024: lot 2210623: (b)(4) items manufactured and released on 25-aug-2022.Expiration date: 2027-aug-01.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: one year after primary cemented tka, the patient complains about anterior knee pain.The patella had not been resurfaced.We understand that the main cause for further surgery was the need to treat the patello-femoral joint, so we would consider it disease progression.However, once the joint was opened, some doubts arose about the stability of the tibial component, and they decided to exchange it to a new one.From the radiographs supplied, we cannot detect a mobilization of the tray or a defect in the implantation, so we assume that the exchange has been carried out for prudence, a thoroughly understandable decision.No reason to suspect a faulty device.

• Brand Name: GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 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: 18613587
• Report Number: 3005180920-2024-00017
• Device Sequence Number: 7565650
• Product Code: JWH
• UDI-Device Identifier: 07630030827143
• UDI-Public: 07630030827143
• 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: 2023
• Device Explanted Year: 2024
• 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): 01/31/2024

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 Catalogue Number: 02.12.T3I4R
• Device Lot Number: 2210623
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2024
• Initial Report FDA Received Date: 01/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/25/2022
• 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: 56 YR
• Patient Sex: Female
• Patient Weight: 117 KG