MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY FULL-PE PS TIBIAL COMPONENT SIZE 3/10

Catalog Number	02.07.0310APPS
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	03/13/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 09 april 2018; lot 166849: (b)(4) items manufactured and released on 02 february 2017.Expiration date: 2022-01-04; no anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by medical affairs on 23 march 2018: tibial component revision occurred 6 months after primary total knee arthroplasty.The patient was complaining about instability and long-axis x-ray show a varus alignment of the knee.No immediate postoperative radiograph is available and the initial position of the implant cannot be assessed.The reason of this event cannot be determined.
Event or Problem Description
The patient came in complaining of instability 7 months after the primary.The right knee was varus.The surgeon revised the tibia.The surgery was completed successfully.

• Brand Name: GMK-PRIMARY FULL-PE PS TIBIAL COMPONENT SIZE 3/10
• Common Device Name: FULL-PE PS TIBIAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7412280
• Report Number: 3005180920-2018-00219
• Device Sequence Number: 13768984
• Product Code: JWH
• UDI-Device Identifier: 07630030817014
• UDI-Public: 07630030817014
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K131310
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/10/2018

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: 01/04/2022
• Device Catalogue Number: 02.07.0310APPS
• Device Lot Number: 166849
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2018
• Initial Report FDA Received Date: 04/10/2018
• 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