MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY FEMUR STD CEMENTED SIZE 2 R; KNEE CEMENTED FEMUR

Model Number	02.07.2002R
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	07/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 18-august-2020: lot 103244: (b)(4) items manufactured and released on 23-nov-2010.Expiration date: 31-10-2015.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any other similar reported event since 2016.Additional device involved: batch review performed on 18-august-2020: gmk-primary 02.07.1203r tibial tray fixed cemented size 3 r (k090988) lot 103290: (b)(4) items manufactured and released on 19-nov-2010.Expiration date: 31.10.2015.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any other similar reported event since 2016.
Event or Problem Description
The patient came in after 9 years and 2 months form the primary surgery for a post-op appointment.X-rays indicated a loose femoral component and tibial tray.The surgeon revised the femoral component, tibial tray, and insert.The surgery was completed successfully.

• Brand Name: GMK-PRIMARY FEMUR STD CEMENTED SIZE 2 R
• Common Device Name: KNEE CEMENTED FEMUR
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10458656
• Report Number: 3005180920-2020-00560
• Device Sequence Number: 2199255
• Product Code: JWH
• UDI-Device Identifier: 07630030820182
• UDI-Public: 07630030820182
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/27/2020

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: 10/31/2015
• Device Model Number: 02.07.2002R
• Device Catalogue Number: 02.07.2002R
• Device Lot Number: 103244
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2020
• Initial Report FDA Received Date: 08/27/2020
• 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