MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION FIXED TIBIAL INSERT SC SIZE 2/20MM; KNEE TIBIAL INSERT

Catalog Number	02.07.0220SCF
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	05/28/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 27 june 2024: lot 189528: (b)(4) items manufactured and released on 20-dec-2018.Expiration date: 2023-12-17.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Clinical evaluation performed by medical affairs department: 2.5 years after revision tka, the patella dislocated laterally and the knee was painful.According to report, a probable cause for this dislocation was suboptimal orientation of the components; in fact, in order to solve the problem, the surgeon decided to explant the former devices and reposition new ones, with new bone cuts.A secondary laxity of the medial collateral ligament probably contributed to the poor outcome perceived by the patient.Neither of the situations seems to be attributable to a defective device.Additional revised implants: batch review performed on 27 june 2024 on gmk-revision 02.07.0682r revision fixed tibial tray cemented size 2 r (k123721) lot.184299.Lot 184299: (b)(4) items manufactured and released on 05-july-2018.Expiration date: 2023-07-03.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported event during the period of review.Batch review performed on 27 june 2024 on gmk-revision 02.07.2403r femur revision ps size 3 r (k102437) lot.1904774.Lot 1904774: (b)(4) items manufactured and released on 05-sep-2019.Expiration date: 2024-08-31.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported event during the period of review.
Event or Problem Description
At about 2 years 6 months after the medacta primary, the patient came in reporting pain due to a dislocating competitor's patella implant and a very loose medial collateral ligament and the cause is unknown.The surgeon revised the patient from gmk-revision to gmk- hinge.The surgery was completed successfully.

• Brand Name: GMK-REVISION FIXED TIBIAL INSERT SC SIZE 2/20MM
• 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: 19623608
• Report Number: 3005180920-2024-00453
• Device Sequence Number: 6237033
• Product Code: JWH
• UDI-Device Identifier: 07630030816932
• UDI-Public: 07630030816932
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K103170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 06/27/2024

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 Expiration Date: 12/17/2023
• Device Catalogue Number: 02.07.0220SCF
• Device Lot Number: 189528
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2024
• Initial Report FDA Received Date: 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/20/2018
• 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 Sex: Unknown