MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 5/12 MM R; KNEE TIBIAL INSERT

Model Number	02.12.0512FR
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 19 april 2021: lot 172827: (b)(4) items manufactured and released on 13 july 2017.Expiration date: 2022-06-23.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold and 2 other similar events have been reported.
Event or Problem Description
The patient had a primary knee surgery on (b)(6) 2017.On (b)(6) 2017, the patient came in due to signs of infection.The surgeon downsized the poly from a 13mm to a 12mm.The surgery was completed successfully.On (b)(6) 2021, 3 years 5 months after the previous surgery the patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and revised the poly and the surgery was completed successfully.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 5/12 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: 11770231
• Report Number: 3005180920-2021-00361
• Device Sequence Number: 17025900
• Product Code: JWH
• UDI-Device Identifier: 07630030826788
• UDI-Public: 07630030826788
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• 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: 06/23/2022
• Device Model Number: 02.12.0512FR
• Device Catalogue Number: 02.12.0512FR
• Device Lot Number: 172827
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2021
• 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