MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY FEMUR STD CEMENTED SIZE 4 L; CEMENTED FEMORAL COMPONENT

Model Number	02.07.2004L
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed by medacta regulatory affairs department on 6-jul-2020 lot 123023: (b)(4) items manufactured and released on 2-oct-2012.Expiration date: 31.08.2017.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any other similar reported event since 2016.Additional implant involved: gmk-primary 02.07.0310sf tibial insert std fixed size 3 / 10 mm (k090988) lot.113005.Batch review performed by medacta regulatory affairs department on 6-jul-2020: lot 113005: (b)(4) items manufactured and released on 31-oct-2011.Expiration date: 30.09.2016.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any other similar reported event since 2016.
Event or Problem Description
The patient came in after 7 years and 3 months after the primary surgery reporting pain due to an aseptic loosening of the femoral component and tibial tray.The surgeon revised the femoral component, tibial tray and poly.The surgery was completed successfully.

• Brand Name: GMK-PRIMARY FEMUR STD CEMENTED SIZE 4 L
• Common Device Name: CEMENTED FEMORAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10288183
• Report Number: 3005180920-2020-00437
• Device Sequence Number: 19066493
• Product Code: JWH
• UDI-Device Identifier: 07630030820212
• UDI-Public: 07630030820212
• 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: 2013
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/17/2020

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: 08/31/2017
• Device Model Number: 02.07.2004L
• Device Catalogue Number: 02.07.2004L
• Device Lot Number: 123023
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2020
• Initial Report FDA Received Date: 07/17/2020
• 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
• Patient Age: 63 YR