MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S1 RM; KNEE FENORAL IMPLANT

Catalog Number 02.18.001RM

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Joint Disorder (2373)

Event Date 12/02/2019

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 06 december 2019: lot 170777: (b)(4) items manufactured and released on 05-may-2017.Expiration date: 2022-04-25.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Batch reviews performed on 06 december 2019.Moto partial knee 02.18.If2.08.Rm tibial insert fix s2 rm - 8mm (k162084) lot 182138: 32 items manufactured and released on 10-jul-2018.Expiration date: 2023-06-05.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Moto partial knee 02.18.Tf2.Rm tibial tray fix cemented s2 rm (k162084) lot 184276: (b)(4) items manufactured and released on 02-oct-2018.Expiration date: 2023-09-19.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.

Event Description

The patient came in complaining of anterior knee pain.The cause of the pain is unknown.The surgeon revised the partial knee femoral component, tibial tray, and insert and converted them to total knee components 7 months after primary.The surgery was completed successfully.

• Brand Name: MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S1 RM
• Type of Device: KNEE FENORAL IMPLANT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 9494688
• MDR Text Key: 173878633
• Report Number: 3005180920-2019-01088
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 07630030895548
• UDI-Public: 07630030895548
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162084
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/25/2022
• Device Catalogue Number: 02.18.001RM
• Device Lot Number: 170777
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/02/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/05/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention