MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/14 MM L; KNEE TIBIAL INSERT

Model Number	02.12.0514FL
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	03/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 1 year and 1 month after the primary surgery, the patient came in reporting pain due to left knee instability.No infection and no loosening of the implants were found.The surgeon revised successfully the tibial tray (size 5), with a tray of the same size, and the insert (from 14mm to 12mm) and implanted two tibial wedges cemented (10mm) and an extension stem (11mm/65mm).
Additional Manufacturer Narrative
Batch review performed on 03-apr-2023.Lot 1900400: (b)(4) items manufactured and released on 08-may-2019.Expiration date: 2024-04-23.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with another similar reported case during the period of review.Additional device involved: batch review performed on 03-apr-2023.Gmk-sphere 02.07.1205l tibial tray fixed cemented size 5 l (k090988) lot 2111935: (b)(4) items manufactured and released on 13-dec-2021.Expiration date: 2026-11-24.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no other similar reported cases during the period of review.Clinical evaluation performed by medacta medical affairs director: 1 year after primary cemented tka the patient complains about instability.The surgeon proceeds to a new operation and reports that the probable cause is posterior pain.He replaces the tibial tray adding augments and stem.It is conceivable that a problem may have occurred during primary surgery with the cementation phase: in one picture the medial cementation of the baseplate looks suboptimal.The surgeon proceeds with a new tibia resection and adds wedges, but no other probable cause of failure was identified.Such an early failure, particularly in a cmented tka, leads to suspect a technical problem that could not be detected at the time of index surgery.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/14 MM 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: 16807150
• Report Number: 3005180920-2023-00285
• Device Sequence Number: 3034590
• Product Code: JWH
• UDI-Device Identifier: 07630030826818
• UDI-Public: 07630030826818
• 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: 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): 04/25/2023

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 Expiration Date: 04/23/2024
• Device Model Number: 02.12.0514FL
• Device Catalogue Number: 02.12.0514FL
• Device Lot Number: 1900400
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2023
• Initial Report FDA Received Date: 04/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/08/2019
• 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: 75 YR
• Patient Sex: Male
• Patient Weight: 97 KG