MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE CR SIZE 4/12 MM L

Model Number	02.12.0412CRL
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 27 december 2019 lot 185590: (b)(4) items manufactured and released on 16-oct-2018.Expiration date: 2023-10-02.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
The patient had a primary knee surgery on (b)(6) 2019.On (b)(6) 2019, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout on the patient and did not remove or revise any components.Presently, on (b)(6)2019 (23 days after primary), the patient came in due to an open wound and signs of an infection.The surgeon performed an i&d and revised the poly.The surgery was completed successfully.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE CR SIZE 4/12 MM L
• Common Device Name: TIBIAL INSERT FIXED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9616220
• Report Number: 3005180920-2019-01160
• Device Sequence Number: 16748321
• Product Code: JWH
• UDI-Device Identifier: 07630040707510
• UDI-Public: 07630040707510
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K181635
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/22/2020

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: 10/02/2023
• Device Model Number: 02.12.0412CRL
• Device Catalogue Number: 02.12.0412CRL
• Device Lot Number: 185590
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/24/2019
• Initial Report FDA Received Date: 01/22/2020
• 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