MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S2 LM; KNEE FEMORAL IMPLANT

Model Number	02.18.002LM
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	06/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2020.Lot 174106: 40 items manufactured and released on 12-oct-2017.Expiration date: 2022-09-05.No anomalies found related to the problem.To date, 33 items of the same lot have been already sold without any similar reported event.Additional devices involved batch reviewsperformed on (b)(6) 2020.Moto partial knee 02.18.If2.09.Lm tibial insert fix s2 lm - 9mm (k162084) lot 168001: 24 items manufactured and released on 24-jan-2017.Expiration date: 2021-12-18.No anomalies found related to the problem.To date, 8 items of the same lot have been already sold without any similar reported event.Moto partial knee 02.18.Tf2.Lm tibial tray fix cemented s2 lm (k162084) lot 184280: 10 items manufactured and released on 07-sep-2018.Expiration date: 2023-08-29.No anomalies found related to the problem.To date, 9 items of the same lot have been already sold without any similar reported event.
Event or Problem Description
The patient came in reporting pain and the cause of pain is unknown.The surgeon revised all implants and converted the moto knee to a total knee.The surgery was completed successfully.

• Brand Name: MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S2 LM
• Common Device Name: KNEE FEMORAL IMPLANT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10263648
• Report Number: 3005180920-2020-00411
• Device Sequence Number: 19599561
• Product Code: HSX
• UDI-Device Identifier: 07630030895555
• UDI-Public: 07630030895555
• Combination Product (Y/N): N
• 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
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/13/2020

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: 09/05/2022
• Device Model Number: 02.18.002LM
• Device Catalogue Number: 02.18.002LM
• Device Lot Number: 174106
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2020
• Initial Report FDA Received Date: 07/13/2020
• 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
• Patient Age: 52 YR