MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 5/13 MM L; KNEE TIBIAL INSERT

Model Number	02.12.0513FL
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 28 april 2021: lot 2002759: (b)(4) items manufactured and released on 10.Jun.2020.Expiration date: 2025-05-27.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.
Event or Problem Description
The patient had a primary knee surgery on (b)(6) 2018.On (b)(6) 2021, the patient came in reporting instability due to laxity.The surgeon revised gmk-sphere tibial insert - flex s5l - 12 mm with a sphere insert flex left 13mm s5 to give the patient more stability.The surgery was completed successfully.On (b)(6) 2021, 1 month after revision surgery for instability, 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 5/13 MM L
• Common Device Name: KNEE TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11804171
• Report Number: 3005180920-2021-00380
• Device Sequence Number: 3646968
• Product Code: JWH
• UDI-Device Identifier: 07630030862656
• UDI-Public: 07630030862656
• 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): 05/09/2021

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: 05/27/2025
• Device Model Number: 02.12.0513FL
• Device Catalogue Number: 02.12.0513FL
• Device Lot Number: 2002759
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2021
• Initial Report FDA Received Date: 05/11/2021
• 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
• Patient Age: 78 YR