MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S3 RM

Model Number	02.18.003RM
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2020.Lot 189249: 48 items manufactured and released on 13-mar-2019.Expiration date: 02-mar-2024.No anomalies found related to the problem to date, 46 items of the same lot have been already sold without any other similar reported event.Other device involved in the event.Moto partial knee 02.18.Tf4.Rm tibial tray fix cemented s4 rm lot.189256 (k162084).Batch review performed on (b)(6) 2020.Lot 189256: 50 items manufactured and released on 27-feb-2019.Expiration date: 17-feb-2024.No anomalies found related to the problem.To date, 41 items of the same lot have been already sold without any other similar reported event.Moto partial knee 02.18.If4.09.Rm tibial insert fix s4 rm - 9mm lot.189282 (k162084) batch review performed on (b)(6) 2020.Lot 189282: 35 items manufactured and released on 09-apr-2019.Expiration date: 26-mar-2024.No anomalies found related to the problem.To date, 26 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 11 months after the primary surgery.The surgeon revised all moto implants to sphere implants.The surgery was completed successfully.

• Brand Name: MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S3 RM
• Common Device Name: ANATOMICAL FEMORAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10755026
• Report Number: 3005180920-2020-00750
• Device Sequence Number: 1138695
• Product Code: HSX
• UDI-Device Identifier: 07630030895586
• UDI-Public: 07630030895586
• Combination Product (Y/N): Y
• 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: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/29/2020

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: 03/02/2024
• Device Model Number: 02.18.003RM
• Device Catalogue Number: 02.18.003RM
• Device Lot Number: 189249
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2020
• Initial Report FDA Received Date: 10/29/2020
• 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