MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S6 RM

Model Number	02.18.006RM
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	12/22/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 18 january 2021: lot 167879: (b)(4) items manufactured and released on 15-feb-2017.Expiration date: 2022-02-06.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.Additional items involved in the event, batch review performed on 18 january 2021 moto partial knee 02.18.Tf7.Rm tibial tray fix cemented s7 rm (k162084) lot.172242 lot 172242: (b)(4) items manufactured and released on 02-jun-2017.Expiration date: 2022-05-18.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.Moto partial knee 02.18.If7.09.Rm tibial insert fix s7 rm - 8mm (k162084) lot.167842 lot 167842: (b)(4) items manufactured and released on 17-jan-2017.Expiration date: 2021-12-14.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 patient came in reporting instability due to loose ligaments that have stretched over time.The surgeon revised the femoral component, tibial tray, and insert 2 years and 1 month after primary.The surgery was completed successfully.Gmk sphere system with 14mm liner has been implanted.

• Brand Name: MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S6 RM
• Common Device Name: ANATOMICAL FEMORAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11207366
• Report Number: 3005180920-2021-00056
• Device Sequence Number: 16987434
• Product Code: HSX
• UDI-Device Identifier: 07630030895647
• UDI-Public: 07630030895647
• 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: 2018
• 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): 01/21/2021

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: 02/06/2022
• Device Model Number: 02.18.006RM
• Device Catalogue Number: 02.18.006RM
• Device Lot Number: 167879
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2020
• Initial Report FDA Received Date: 01/21/2021
• 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