MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE EXTENSION STEM - FLUTED Ø 11 L 65

Catalog Number	02.07.FCL11065
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	08/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs director: femoral fracture occurred 3 years after hinged knee prosthesis implantation.Information concerning patient age, health status and presence of comorbidities is not available.The cause of fracture cannot be determined on the basis of available information but it is hardly related to implanted devices.Batch review performed on (b)(6) 2019: lot 154987: (b)(4) items manufactured and released on 12/01/2015.Expiration date: 11/17/2020.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.
Event or Problem Description
The gmk hinge was implanted in the patient on (b)(6) 2016 revising a system of competitor.In an unknown date the patient had a peri-prosthetic fracture at stem femur level and was operated to cable the femur and to insert a plate to fix the bone fracture.3 years after gmk hinge implantation the patient had a new at peri-prosthetic fracture at femur stem level.The surgeon revised all the femoral components implanting a longer femur stem and new femoral components.The surgery was completed successfully.

• Brand Name: GMK-HINGE EXTENSION STEM - FLUTED Ø 11 L 65
• Common Device Name: EXTENSION STEM - FLUTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8992822
• Report Number: 3005180920-2019-00758
• Device Sequence Number: 14283936
• Product Code: JWH
• UDI-Device Identifier: 07630030822872
• UDI-Public: 07630030822872
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K120790
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/11/2019

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: 11/17/2020
• Device Catalogue Number: 02.07.FCL11065
• Device Lot Number: 154987
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2019
• Initial Report FDA Received Date: 09/11/2019
• 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