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

Catalog Number	02.18.001RM
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	12/02/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: KNEE FENORAL IMPLANT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9494688
• Report Number: 3005180920-2019-01088
• Device Sequence Number: 16447897
• Product Code: HSX
• UDI-Device Identifier: 07630030895548
• UDI-Public: 07630030895548
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K162084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/19/2019

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: 04/25/2022
• Device Catalogue Number: 02.18.001RM
• Device Lot Number: 170777
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2019
• Initial Report FDA Received Date: 12/19/2019
• 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