MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION FIXED TIBIAL TRAY CEMENTED SIZE 4 L

Model Number	02.07.0684L
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 23 august 2021: lot 1901730: 15 items manufactured and released on 18-july-2019.Expiration date: 2024-07-07.No anomalies were found related to the problem.To date, 12 items of the same lot have been sold without any similar reported event.Additional item involved in the event, batch review performed on 23 august 2021: gmk-revision 02.07.0412psf tibial insert ps fixed size 4/12mm (k090988) lot.179573 lot 179573: 75 items manufactured and released on 20-mar-2018.Expiration date: 2023-03-09.No anomalies found related to the problem.To date, 64 items of the same lot have been sold without any similar reported event.
Event or Problem Description
The patient had a primary knee surgery and was implanted with competitor products.On (b)(6) 2020, the patient had the competitor products revised to medacta products for reasons unknown.9 months after meacta product implantation, on (b)(6) 2021, the patient came in reporting pain and the cause of the pain is unknown.The surgeon revised the tibial tray and liner.The surgery was completed successfully.

• Brand Name: GMK-REVISION FIXED TIBIAL TRAY CEMENTED SIZE 4 L
• Common Device Name: FIXED TIBIAL TRAY
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12433081
• Report Number: 3005180920-2021-00719
• Device Sequence Number: 3308740
• Product Code: JWH
• UDI-Device Identifier: 07630030819384
• UDI-Public: 07630030819384
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K123721
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/07/2021

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: 07/07/2024
• Device Model Number: 02.07.0684L
• Device Catalogue Number: 02.07.0684L
• Device Lot Number: 1901730
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2021
• Initial Report FDA Received Date: 09/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention