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

Model Number	3031.0205
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	01/01/2004
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 23 december 2019.Lot 03-0174: (b)(4) items manufactured and released on 12-jun-2003.Expiration date: 2008-05-31.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.Preliminary investigation performed by r&d project manager.Revision surgery after 15 years from primary implantation due to aseptic tibial loosening.From the picture of the explanted implant, no residual cement can be identified on the distal surface of the tibia tray and on the internal part of the femoral component.Absence or lack of cement on explanted components is usual to be seen even if the cause of revision is not loosening or mobilization.Surface finishing seem to be in compliance with the specifications required and no loss of mechanical properties that could have contributed to the event can be noted.From preliminary investigation there is no evidence that the event is related to a faulty device.
Event or Problem Description
Revision surgery performed on (b)(6) 2019 due to a tibial loosening.Primary surgery took place in 2004, exact date unknown.The surgery was completed successfully.
Additional Manufacturer Narrative
We discovered on the (b)(6) 2020, the complete date of birth of the patient: (b)(6) 1930.

• 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, 6874 ; SZ 6874
• MDR Report Key: 9601766
• Report Number: 3005180920-2019-01152
• Device Sequence Number: 16860484
• Product Code: JWH
• UDI-Device Identifier: 07630030845284
• UDI-Public: 07630030845284
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K081023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2020

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: 05/31/2008
• Device Model Number: 3031.0205
• Device Catalogue Number: 3031.0205
• Device Lot Number: 03-0174
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2019
• Supplement Date Received by Manufacturer: 12/19/2019
• Initial Report FDA Received Date: 01/17/2020
• Supplement Report FDA Received Date: 04/07/2020
• 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: 89 YR