MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MYKNEE FEMUR DISTAL CUTTING BLOCK - CT - GMK - RIGHT MEDIAL - SIZE3; FEMUR CUTTING BLOCK

Catalog Number	4.1023S
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 16-may-2018.Other device involved: myknee femur bone model - right - sterile.Lot 62463k: (b)(4) items manufactured and released on 20-may-2018.Expiration date: 2018-08-29.No anomalies found related to the problem.Both cutting block and femur bone model involved in this case are of the lot 62463k.Analysis performed from the medacta mysolution department on the 27th april 2018: our analysis of the myknee process of this case found no deviations from the standard procedures.Each step has been performed correctly.
Event or Problem Description
The cuts on the myknee femur block left the femur about 10-15 degrees more in valgus despite of the planned 3 degrees.There was even a noticeable valgus on the femur bone model.The surgery was completed with several re cuts of the distal femur and the patient was left in 1 degree of valgus.

• Brand Name: MYKNEE FEMUR DISTAL CUTTING BLOCK - CT - GMK - RIGHT MEDIAL - SIZE3
• Common Device Name: FEMUR CUTTING BLOCK
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7522285
• Report Number: 3005180920-2018-00336
• Device Sequence Number: 1224488
• Product Code: JWH
• UDI-Device Identifier: 07630030865855
• UDI-Public: 07630030865855
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K093806
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/29/2018
• Device Catalogue Number: 4.1023S
• Device Lot Number: 62463K
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2018
• Initial Report FDA Received Date: 05/17/2018
• 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: Other
• Patient Age: 74 YR