MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION FEMUR REVISION PS SIZE 3 L; KNEE CEMENTED FEMUR

Model Number	02.07.2403L
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	09/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed by medacta regulatory affairs department: lot 180124: (b)(4) items manufactured and released on 30-apr-2018.Expiration date: 19-apr-2023.No anomalies found related to the problem.To date, 18 items of the same lot have been already sold without any other similar reported event.Clinical evaluation performed by medacta medical affairs manager: 1 year and 4 months after cemented tka the femur is exchanged to a revision component of smaller size.The stiffness and pain reported by the patient may be due to the excessive size of the primary femoral component and the empty volume between anterior shield and bone.No reason to suspect a faulty device in this case.
Event or Problem Description
Revision surgery performed after 1 year and 4 months due to stiffness in the knee probably due to an oversized femur.The surgeon revised all components.The surgery was completed successfully.

• Brand Name: GMK-REVISION FEMUR REVISION PS SIZE 3 L
• Common Device Name: KNEE CEMENTED FEMUR
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10640903
• Report Number: 3005180920-2020-00684
• Device Sequence Number: 4044215
• Product Code: JWH
• UDI-Device Identifier: 07630030821400
• UDI-Public: 07630030821400
• 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: 2019
• Device Explanted Year: 2020
• 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): 10/07/2020

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: 04/19/2023
• Device Model Number: 02.07.2403L
• Device Catalogue Number: 02.07.2403L
• Device Lot Number: 180124
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2020
• Initial Report FDA Received Date: 10/07/2020
• 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