MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S4 RM; KNEE FEMORAL UNICOMPARTIMENTAL CEMENTED COMPONENT

Catalog Number	02.18.004RM
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 17 june 2019: lot 182117: (b)(4) items manufactured and released on 13-june-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.Additional devices involved: moto partial knee 02.18.Tf4.Rm tibial tray fix cemented s4 rm (k162084) lot 167758: (b)(4) items manufactured and released on 21-feb-2017.Expiration date: 2022-02-07.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold.Moto partial knee 02.18.If4.08.Rm tibial insert fix s4 rm - 8mm (k162084) lot.182149: (b)(4) items manufactured and released on 19-jun-2018.Expiration date: 2023-05-05.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold.
Event or Problem Description
The patient came in complaining of pain 6 months after primary and the cause of pain is unknown.The surgeon revised the medacta uni-knee to another company's total-knee.The surgery was completed successfully.

• Brand Name: MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S4 RM
• Common Device Name: KNEE FEMORAL UNICOMPARTIMENTAL CEMENTED COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8764333
• Report Number: 3005180920-2019-00536
• Device Sequence Number: 2039680
• Product Code: HSX
• UDI-Device Identifier: 07630030895609
• UDI-Public: 07630030895609
• 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: 2018
• 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): 07/05/2019

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: 06/05/2023
• Device Catalogue Number: 02.18.004RM
• Device Lot Number: 182117
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2019
• Initial Report FDA Received Date: 07/05/2019
• 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