MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE TIBIAL TRAY FIX CEMENTED S3 RM

Catalog Number	02.18.TF3.RM
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	09/04/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 01 october 2018; lot 167756: (b)(4) items manufactured and released on 15 february 2017.Expiration date: 2022-02-05.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.Clinical evaluation performed by medical affairs manager on october 04, 2018 early loosening of a unicompartmental knee replacement occurred 2 months after primary surgery.Radiographic image provided doesn't allow a proper clinical investigation: no immediate post primary image is available.On the basis of information received, no conclusion can be drawn.
Event or Problem Description
Revision due to loosening of the tibial tray 2 months after the primary, due to a weakening of the underlying bone stock.The surgeon revised all the devices.

• Brand Name: MOTO PARTIAL KNEE TIBIAL TRAY FIX CEMENTED S3 RM
• Common Device Name: TIBIAL TRAY FIX CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7933739
• Report Number: 3005180920-2018-00743
• Device Sequence Number: 1514594
• Product Code: HSX
• UDI-Device Identifier: 07630030896743
• UDI-Public: 07630030896743
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K162084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/04/2018

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: 02/05/2022
• Device Catalogue Number: 02.18.TF3.RM
• Device Lot Number: 167756
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2018
• Initial Report FDA Received Date: 10/04/2018
• 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: 66 YR
• Patient Weight: 95