MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA TIBIAL INSERT FIXED SPHERE FLEX SIZE 6/11 MM L

Catalog Number	02.12.0611FL
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	06/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 17 july 2018: lot 154755 : (b)(4) items manufactured and released on 14 january 2016.Expiration date: 2020-12-19 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.Reference 02.12.0026l (k140826) femoral component sphere cemented size 6+ l: lot 142555: (b)(4) items manufactured and released on 06 may 2014.Expiration date:.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.Reference 02.07.1206l (k090988) tibial tray fixed cemented size 6 l: lot 151669: (b)(4) items manufactured and released on 15 june 2015.Expiration date: 2020-05-31 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.
Event or Problem Description
The patient came in due to signs of infection 1 year and 7 months after primary.The patient was positive for staphylococcus epidermis.The surgeon removed all hardware and implanted medacta hardware as a spacer.The surgery was completed successfully.

• Brand Name: TIBIAL INSERT FIXED SPHERE FLEX SIZE 6/11 MM L
• Common Device Name: TIBIAL INSERT FIXED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7698439
• Report Number: 3005180920-2018-00516
• Device Sequence Number: 16406481
• Product Code: JWH
• UDI-Device Identifier: 07630030862687
• UDI-Public: 07630030862687
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K140826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/18/2018

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: 01/14/2016
• Device Catalogue Number: 02.12.0611FL
• Device Lot Number: 154755
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/18/2018
• 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