MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY FEMUR STD CEMENTED SIZE 4 L; CEMENTED KNEE FEMURAL COMPONENT

Model Number	02.07.2004L
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 07 december 2020: lot 123872: (b)(4) tems manufactured and released on 07-nov-2012.Expiration date: 2017-09-30.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any similar reported event since 2016.Additional implant involved: gmk-primary 02.07.1205l tibial tray fixed cemented size 5 l (k090988) lot.113796.Batch review performed on 07 december 2020: lot 113796: (b)(4) tems manufactured and released on 23-nov-2011.Expiration date: 2016-10-31.No anomalies found related to the problem.To date, (b)(4) tems of the same lot have been already sold without any similar reported event since 2016.Additional implant involved: gmk-primary 02.07.0512fuc tibial insert uc fixed size 5 / 12 mm (k090988) lot.114251.Batch review performed on 07 december 2020: lot 114251: (b)(4) tems manufactured and released on 10-feb-2012.Expiration date: 2016-12-31.No anomalies found related to the problem.To date, (b)(4) tems of the same lot have been already sold without any similar reported event since 2016.Additional implant involved: gmk-primary 02.07.0035rp patella resurfacing size 3 (k090988) lot.122440.Batch review performed on 07 december 2020: lot 122440: (b)(4) tems manufactured and released on 16-oct-2012.Expiration date: 2017-08-31.No anomalies found related to the problem.To date, (b)(4) tems of the same lot have been already sold without any similar reported event since 2016.
Event or Problem Description
The patient came in, 7 years and 10 months after primary surgery, due to signs of an infection and the pathogen is unknown.The surgeon removed all components and implanted an antibiotic spacer.The surgery was completed successfully.

• Brand Name: GMK-PRIMARY FEMUR STD CEMENTED SIZE 4 L
• Common Device Name: CEMENTED KNEE FEMURAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11053919
• Report Number: 3005180920-2020-00949
• Device Sequence Number: 14119658
• Product Code: JWH
• UDI-Device Identifier: 07630030820212
• UDI-Public: 07630030820212
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/22/2020

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: 09/30/2017
• Device Model Number: 02.07.2004L
• Device Catalogue Number: 02.07.2004L
• Device Lot Number: 123872
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2020
• Initial Report FDA Received Date: 12/22/2020
• 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