MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHER TIBIAL TRAY FIXED CEMENTED SIZE 2 L; KNEE TIBIAL INSERT

Model Number	02.07.1202L
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	05/26/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery for cemented tibial tray loosening, causing knee instability, 1 year and 8 months post primary.Tibial tray and liner were revised successfully.
Additional Manufacturer Narrative
Batch review performed on 30 may 2023: lot 2011074: 131 items manufactured and released on 11-mar-2021.Expiration date: 2026-02-24.No anomalies found related to the problem.To date, 124 items of the same lot have been sold without any similar reported event in the period of review.

• Brand Name: GMK-SPHER TIBIAL TRAY FIXED CEMENTED SIZE 2 L
• Common Device Name: KNEE TIBIAL INSERT
• 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: 17161710
• Report Number: 3005180920-2023-00440
• Device Sequence Number: 5654598
• Product Code: JWH
• UDI-Device Identifier: 07630030819865
• UDI-Public: 07630030819865
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/20/2023

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: 02/24/2026
• Device Model Number: 02.07.1202L
• Device Catalogue Number: 02.07.1202L
• Device Lot Number: 2011074
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2023
• Initial Report FDA Received Date: 06/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/11/2021
• 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: 64 YR
• Patient Sex: Female
• Patient Weight: 106 KG
• Patient Race: Black Or African American