MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA FEMORAL COMPONENT SPHERE CEMENTED SIZE 6 L; FEMORAL COMPONENT CEMENTED

Catalog Number	02.12.0006L
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/28/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 25 june 2018.Lot 155735: (b)(4) items manufactured and released on 11 january 2016.Expiration date: 2020-12-07.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.Gmk-sphere primary extension stem ø11mm / l 30 mm reference (b)(4): lot 162050: (b)(4) items manufactured and released on 25 may 2016.Expiration date: 2021-04-11 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.Gmk-sphere tibial insert fixed sphere flex size 5/14 mm l reference (b)(4): lot 152438: (b)(4) items manufactured and released on 10 november 2015.Expiration date: 17.10.2020.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.Gmk-sphere patella resurfacing size 4 reference (b)(4): lot 160955: (b)(4) items manufactured and released on 12 may 2016.Expiration date: 21.04.2021 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.Gmk-sphere tibial tray fixed cemented size 5 l reference (b)(4): lot 156425: (b)(4) items manufactured and released on 26 february 2016.Expiration date: 2021-04-11.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 had a primary on (b)(6) 2016.On (b)(6) 2017 the patient came in due to signs of infection [pathogen not available].The surgeon washed out the knee and swapped the poly.(mdr 2017-00602) on (b)(6) 2018 the patient was revised again.The patient came in due to signs of infection.Pathogen unknown.The surgeon pulled all hardware and implanted a spacer.The surgery was completed successfully.
Additional Manufacturer Narrative
Additional information received on (b)(6) 2019 about 1 year and 1 month after spacer implantation, on (b)(6) 2019, the antibiotic spacer was removed and permanent hardware was implanted.The surgery was completed successfully.

• Brand Name: FEMORAL COMPONENT SPHERE CEMENTED SIZE 6 L
• Common Device Name: FEMORAL COMPONENT CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7634070
• Report Number: 3005180920-2018-00459
• Device Sequence Number: 1187606
• Product Code: JWH
• UDI-Device Identifier: 07630030825873
• UDI-Public: 07630030825873
• 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,Followup
• Report Date (Section B): 07/12/2019

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: 12/07/2020
• Device Catalogue Number: 02.12.0006L
• Device Lot Number: 155735
• 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: 05/28/2018
• Supplement Date Received by Manufacturer: 05/28/2018
• Initial Report FDA Received Date: 06/25/2018
• Supplement Report FDA Received Date: 07/12/2019
• 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