MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S5 - LATER; KNEE FEMORAL COMPONENT

Catalog Number	02.18.105LLRL
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 04 december 2020: lot 1906794: (b)(4) items manufactured and released on 13-nov-2019.Expiration date: 2024-11-02.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Additional device involved: batch reviews performed on 04 december 2020: moto partial knee 02.18.If6.08.Llrl tibial insert fix s6 - lateral - 8mm (k183029) lot 1906756: (b)(4) items manufactured and released on 31-oct-2019.Expiration date: 2024-10-12.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Moto partial knee 02.18.Tf6.Rl tibial tray fix cemented s6 rl (k183029) lot 1906787: (b)(4) items manufactured and released on 11-dec-2019.Expiration date: 2024-11-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
Event or Problem Description
The patient came in, one month after primary surgery, reporting pain due to osteoporosis.The surgeon revised the femoral component, tibial tray, and insert.The surgery was completed successfully.

• Brand Name: MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S5 - LATER
• Common Device Name: KNEE FEMORAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11017686
• Report Number: 3005180920-2020-00939
• Device Sequence Number: 3822899
• Product Code: HSX
• UDI-Device Identifier: 07630040720694
• UDI-Public: 07630040720694
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K183029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/16/2020

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: 11/02/2024
• Device Catalogue Number: 02.18.105LLRL
• Device Lot Number: 1906794
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2020
• Initial Report FDA Received Date: 12/16/2020
• 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