MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 2/11 MM R; KNEE TIBIAL INSERT

Model Number	02.12.0211FR
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 03-may-2021: lot 1901313: (b)(4) items manufactured and released on 03-jun-2019.Expiration date: 2024-05-19.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
Revision surgery performed due to infection after about 1 month from the primary surgery, the pathogen is unknown.The surgeon performed a washout and revised the poly and the surgery was completed successfully.The patient already underwent revision surgery, it was due to the tibial tray subsidence, this happened about 1 month ago, with respect to this surgery.The surgeon revised the tibial tray and insert and added a fluted extension stem and tibial augment.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 2/11 MM R
• Common Device Name: KNEE TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11770208
• Report Number: 3005180920-2021-00357
• Device Sequence Number: 11644450
• Product Code: JWH
• UDI-Device Identifier: 07630030862540
• UDI-Public: 07630030862540
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K140826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/04/2021

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: 05/19/2024
• Device Model Number: 02.12.0211FR
• Device Catalogue Number: 02.12.0211FR
• Device Lot Number: 1901313
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2021
• Initial Report FDA Received Date: 05/04/2021
• 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