MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION FEMUR REVISION PS SIZE 4 L

Model Number	02.07.2404L
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	09/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2020.Lot 1906423: (b)(4) items manufactured and released on 05-nov-2019.Expiration date: 2024-10-22.No anomalies found related to the problem.To date, 7 items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
The patient came in reporting pain due to a fracture at femoral level that was caused from the patient stepping and twisting her leg.The surgeon cabled and plated the fracture and did not revise any components 1 month after previous surgery.The surgery was completed successfully.The patient had a primary implanted with competitor products, on (b)(6) 2020 the competitor products were revised with medacta products.

• Brand Name: GMK-REVISION FEMUR REVISION PS SIZE 4 L
• Common Device Name: FEMUR REVISION
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10634600
• Report Number: 3005180920-2020-00683
• Device Sequence Number: 16945153
• Product Code: JWH
• UDI-Device Identifier: 07630030821424
• UDI-Public: 07630030821424
• Combination Product (Y/N): Y
• 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: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/06/2020

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: 10/22/2024
• Device Model Number: 02.07.2404L
• Device Catalogue Number: 02.07.2404L
• Device Lot Number: 1906423
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2020
• Initial Report FDA Received Date: 10/06/2020
• 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