MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE FEMORAL COMPONENT SIZE 4 R; KNEE CEMENTED FEMORAL IMPLANT

Catalog Number	02.09.2604R
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	03/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 01 april 2019: lot 168959: (b)(4) items manufactured and released on 26-apr-2017.Expiration date: 2022-04-03.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 director: knee revision surgery 1 year and 3 months after implantation of a hinged total knee prosthesis.No information concerning patient age, comorbidities and previous surgeries is available.Implant mobilization is a possible adverse event after total knee replacement and causes are often unknown.Patients requiring a constrained implant are usually those presenting challenging conditions such as revision surgeries, insufficient ligaments and muscular stabilization and systemic commodities.No conclusion can be drawn on the basis of information received.
Event or Problem Description
Revision surgery performed after 1 year and 2 months due to instability caused by a loose femoral component.The cause of the loosening is unknown.The surgeon revised the femoral component, a tibial tray and insert with another company's product and the surgery was completed successfully.

• Brand Name: GMK-HINGE FEMORAL COMPONENT SIZE 4 R
• Common Device Name: KNEE CEMENTED FEMORAL IMPLANT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8478388
• Report Number: 3005180920-2019-00231
• Device Sequence Number: 13819487
• Product Code: KRO
• UDI-Device Identifier: 07630030825460
• UDI-Public: 07630030825460
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K130299
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/03/2019

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: 04/03/2022
• Device Catalogue Number: 02.09.2604R
• Device Lot Number: 168959
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2019
• Initial Report FDA Received Date: 04/03/2019
• 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