MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA EVOLIS CEMENTED TIBIAL BASEPLATE SIZE 5

Catalog Number	3031.0205
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 20 august 2018.Lot 131465 : (b)(4) items manufactured and released on 15 april 2013.Expiration date: 2018-03-31 no anomalies found related to the problem.To date, all items of the same lot have been already sold without any similar reported event.
Event or Problem Description
Revision due to tibial tray loosening and subsidence 5 years after primary.The patient having a high bmi; no extension stem was implanted in the primary case.The femoral component was left in situ.The sales representative was informed about the event by the surgeon on 28 june 2018.Due to human error, the sales representative informed the headquarter on 10 august 2018.
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs director tibial component revision occurred 5 years after primary cemented tka in a heavy woman.Radiographic images provided show the presence of radiolucent lines at the implant-cement interface and the cement mantle looks discontinued.Aseptic loosening is a possible literature described mid-term adverse event after primary tkr and reasons are often unknown.The cause of this event cannot be determined.Preliminary investigation performed by r&d product manager no considerations on the event can be done looking at the pictures of the explanted tibial component.The distal surface of the component can't be seen.From the event description we can only suppose that mobilization and sinking of the tibial tray could be caused by an high bmi and / or stability not correctly addressed during primary surgery with extension stems.

• Brand Name: EVOLIS CEMENTED TIBIAL BASEPLATE SIZE 5
• Common Device Name: CEMENTED TIBIAL BASEPLATE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7797182
• Report Number: 3005180920-2018-00622
• Device Sequence Number: 1535269
• Product Code: JWH
• UDI-Device Identifier: 07630030845284
• UDI-Public: 07630030845284
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K081023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2018

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: 03/31/2018
• Device Catalogue Number: 3031.0205
• Device Lot Number: 131465
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2018
• Supplement Date Received by Manufacturer: 06/28/2018
• Initial Report FDA Received Date: 08/20/2018
• Supplement Report FDA Received Date: 09/21/2018
• 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: Other
• Patient Age: 72 YR
• Patient Weight: 90