MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION FEMUR REVISION PS SIZE 6 R; CEMENTED FEMORAL COMPONENT

Model Number	02.07.2406R
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Unspecified Tissue Injury (4559)
Date of Event	03/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 31.Mar.2021: lot 1810572: (b)(4) items manufactured and released on 21.03.2019.Expiration date: 2024-03-11.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without other similar reported event.Additional implant involved: gmk-revision 02.07.0517scf fixed tibial insert sc size 5/17mm (k103170) lot.188129.Batch review performed on 31.Mar.2021: lot 188129: (b)(4) items manufactured and released on 21.11.2018.Expiration date: 2023-11-06.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without other similar reported event.
Event or Problem Description
8 months after the primary surgery the patient came in reporting pain and instability.The surgeon observed that the patient had soft tissue damage and a loose femoral component and the cause is unknown.The surgeon revised the femoral component, tibial tray, and insert and added offset connectors, femoral wedges, fluted extension stems and tibial augments.Previously the patient had competitor implants and was revised on (b)(6) 2020 following an infection, medacta implants were used as an antibiotic spacer.On (b)(6) 2020 the permanent medacta hardware was implanted.

• Brand Name: GMK-REVISION FEMUR REVISION PS SIZE 6 R
• Common Device Name: CEMENTED FEMORAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11692160
• Report Number: 3005180920-2021-00318
• Device Sequence Number: 3437964
• Product Code: JWH
• UDI-Device Identifier: 07630030821479
• UDI-Public: 07630030821479
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K102437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/20/2021

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: 03/11/2024
• Device Model Number: 02.07.2406R
• Device Catalogue Number: 02.07.2406R
• Device Lot Number: 1810572
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2021
• Initial Report FDA Received Date: 04/20/2021
• 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