MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION REVISION FIXED TIBIAL TRAY CEMENTED SIZE 4 R; KNEE CEMENTED TIBIAL TRAY

Catalog Number	02.07.0684R
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	03/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 08 april 2019 lot 122885: (b)(4) items manufactured and released on 07-nov-2012.Expiration date: 2017-09-30.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 director: total knee revision occurred 3 years and 5 months after implantation of a total knee arthroplasty in a challenging condition.No information concerning previous surgeries and/or pre implantation bone status is available.The choice of extension stems and augments let us suppose the presence of insufficient bone support during surgery.Radiographic images provided show tibial component subsidence.The reason of this event cannot be determined.
Event or Problem Description
The patient came in, 3 years and 5 months after primary surgery, complaining of pain caused by an aseptic loosening of the tibial tray.The surgeon revised all implants and the surgery was completed successfully.

• Brand Name: GMK-REVISION REVISION FIXED TIBIAL TRAY CEMENTED SIZE 4 R
• Common Device Name: KNEE CEMENTED TIBIAL TRAY
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8508146
• Report Number: 3005180920-2019-00262
• Device Sequence Number: 1781300
• Product Code: JWH
• UDI-Device Identifier: 07630030819391
• UDI-Public: 07630030819391
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K123721
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/12/2019

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: 09/30/2017
• Device Catalogue Number: 02.07.0684R
• Device Lot Number: 122885
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2019
• Initial Report FDA Received Date: 04/12/2019
• 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