MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 R; KNEE TIBIAL TRAY

Catalog Number	02.07.1205R
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 25 july 2023: lot 2111937: 150 items manufactured and released on 18-oct-2021.Expiration date: 2026-10-06.No anomalies found related to the problem.To date, 129 items of the same lot have been sold without any similar reported event during the period of review.Clinical evalaution performed by medacta medical affairs manager: a second revision surgery was performed 8 months after a first revision aimed at resurfacing the patella, in the context of a gmk sphere.After the first revision surgery, the patient solved the previous anterior knee pain, but complained of medial knee pain.From the available x ray images, we can assess a tibial tray slightly medialized.The cause of the medial pain is difficult to determine, but the tibial tray over the edge may have impinged the medial soft tissues developing the symptomatology.The revision surgery provided the change of the tibial tray and the insert.We have no reason to suspect a defective or malfunctioning device.
Event or Problem Description
On (b)(6) 2022 the patient had a primary knee surgery.On (b)(6) 2022, the patient reported anterior knee pain.The surgeon resurfaced the natural patient's patella.Presently on (b)(6) 2023, revision surgery due to cemented tibial tray overhanging.Pain described by the patient.No infection, no loosening of the implants.The surgeon revised successfully the tibial components.

• Brand Name: GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 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: 17388872
• Report Number: 3005180920-2023-00599
• Device Sequence Number: 17671632
• Product Code: JWH
• UDI-Device Identifier: 07630030819933
• UDI-Public: 07630030819933
• 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: 2022
• 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): 07/25/2023

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 Catalogue Number: 02.07.1205R
• Device Lot Number: 2111937
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2023
• Initial Report FDA Received Date: 07/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/29/2021
• 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: 63 YR
• Patient Sex: Male
• Patient Weight: 90 KG