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

Model Number	02.18.004LM
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 22 may 2020: lot 182110: (b)(4) items manufactured and released on 08-jun-2018.Expiration date: 2023-05-28.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.Lot 170793: (b)(4) items manufactured and released on 03-jul-2017.Expiration date: 2022-06-08.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.Lot 167800: (b)(4) items manufactured and released on 09-jan-2017.Expiration date: 2021-12-12.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 surgeon revised the moto knee to a sphere knee and resurfaced the patella 8 months after primary.The reason for the revision was the patient came in reporting pain and the cause of pain is unknown.The revision surgery was successfully completed.

• Brand Name: MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S4 LM
• Common Device Name: PARTIAL KNEE FEMORAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874, CHE; SZ 6874, CHE
• MDR Report Key: 10101058
• Report Number: 3005180920-2020-00302
• Device Sequence Number: 3572882
• Product Code: HSX
• UDI-Device Identifier: 07630030895593
• UDI-Public: 07630030895593
• 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: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/29/2020

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: No Information
• Device Expiration Date: 05/28/2023
• Device Model Number: 02.18.004LM
• Device Catalogue Number: 02.18.004LM
• Device Lot Number: 182110
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2020
• Initial Report FDA Received Date: 05/29/2020
• 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