MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/20 MM R

Catalog Number	02.12.0420FR
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 18 june 2018: lot 132023: (b)(4) items manufactured and released on 10 may 2013.Expiration date: 2018-03-31 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.Other device involved.Reference 02.12.T3i4r tibial tray fixed cemented size t3-i4 r.Lot 170237: (b)(4) items manufactured and released on 09 may 2017.Expiration date: 2018-03-31 no anomalies found related to the problem.To date, (b)(4) item of the same lot have been already sold without any similar reported event.
Event or Problem Description
About 10 month after primary the surgeon revised the patient for knee infection.The surgery was completed successfully.

• Brand Name: TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/20 MM R
• Common Device Name: TIBIAL INSERT FIXED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7619793
• Report Number: 3005180920-2018-00437
• Device Sequence Number: 1383674
• Product Code: JWH
• UDI-Device Identifier: 07630030826702
• UDI-Public: 07630030826702
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/20/2018

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: 03/31/2018
• Device Catalogue Number: 02.12.0420FR
• Device Lot Number: 132023
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2018
• Initial Report FDA Received Date: 06/20/2018
• 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: 74 YR