MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT STD FIXED SIZE 5 / 10 MM; TIBIAL INSERT FIXED

Model Number	02.07.0510SF
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed by medacta regulatory affairs department on 6 november 2020: lot 1900590: 25 items manufactured and released on 20-may-2019.Expiration date: 2024-05-05.No anomalies found related to the problem.To date, 24 items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
Revision surgery performed after 15 days from the primary surgery due to infection.The surgeon revised the insert and performed a washout (diar).There was no cultures growth from the swabs taken but clinically the patient has an infection.

• Brand Name: GMK-PRIMARY TIBIAL INSERT STD FIXED SIZE 5 / 10 MM
• Common Device Name: TIBIAL INSERT FIXED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10905718
• Report Number: 3005180920-2020-00825
• Device Sequence Number: 16905479
• Product Code: JWH
• UDI-Device Identifier: 07630030818240
• UDI-Public: 07630030818240
• Combination Product (Y/N): Y
• Initial Reporter Country: IS
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/05/2024
• Device Model Number: 02.07.0510SF
• Device Catalogue Number: 02.07.0510SF
• Device Lot Number: 1900590
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2020
• Initial Report FDA Received Date: 11/25/2020
• 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: 67 YR
• Patient Weight: 75