MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/11 MM R

Model Number	02.12.0511FR
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/27/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient came in due to signs of infection and the pathogen is unknown.The surgeon performed a washout and revised the poly 17 days after primary.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 28 december 2021: lot 2005770: (b)(4) items manufactured and released on 03-sep-2020.Expiration date: 2025-08-23.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with two similar reported events.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/11 MM R
• Common Device Name: TIBIAL INSERT FIXED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 13342902
• Report Number: 3005180920-2022-00034
• Device Sequence Number: 4737700
• Product Code: JWH
• UDI-Device Identifier: 07630030862663
• UDI-Public: 07630030862663
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/25/2022

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: 08/23/2025
• Device Model Number: 02.12.0511FR
• Device Catalogue Number: 02.12.0511FR
• Device Lot Number: 2005770
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2021
• Initial Report FDA Received Date: 01/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/03/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White