MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/26MM

Catalog Number	02.07.0426SCF
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 22 february 2019.Lot 183193: items manufactured and released on 28 june 2018.Expiration date: 06-18-2023 no anomalies found related to the problem.To date, (b)(4) item of the same lot have been already sold without any similar reported event.
Event or Problem Description
First revision surgery performed due to subluxed tibia, at that time a poly swap was performed.Presently, 1 month after primary surgery, the patient came in complaining of pain due to a subluxed tibia the cause of the subluxation is unknown.A revision surgery has not been scheduled at this time.Surgeon will continue to monitor the patient, may have to use a hinge prosthesis if the patient's knee does not tighten up.

• Brand Name: GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/26MM
• Common Device Name: FIXED TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8361565
• Report Number: 3005180920-2019-00088
• Device Sequence Number: 1924077
• Product Code: JWH
• UDI-Device Identifier: 07630030818141
• UDI-Public: 07630030818141
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K103170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/22/2019

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: 06/18/2023
• Device Catalogue Number: 02.07.0426SCF
• Device Lot Number: 183193
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2019
• Initial Report FDA Received Date: 02/22/2019
• 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