MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY FEMUR STD CEMENTED SIZE 5 L

Model Number	02.07.2005L
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2020.Lot 091256: 16 items manufactured and released on 24-jun-2009.Expiration date: 2014-05-31.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any other similar reported event since 2016.Additional item invovled in the event, batch review performed on (b)(6) 2020.Gmk-primary 02.07.1205l tibial tray fixed cemented size 5 l (k090988) lot.100385 lot 100385: 31 items manufactured and released on 05-may-2010.Expiration date: 2015-03-31.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any other similar reported event since 2016.Gmk-primary 02.07.0510fuc tibial insert uc fixed size 5 / 10 mm (k090988) lot.091789 lot 091789: 24 items manufactured and released on 07-aug-2009.Expiration date: 2014-06-30.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any other similar reported event since 2016.
Event or Problem Description
The patient came in due to signs of infection and the pathogen is unknown.The surgeon performed a washout and revised femoral component, poly and tibial tray 9 years and 11 months after primary.The surgery was completed successfully.

• Brand Name: GMK-PRIMARY FEMUR STD CEMENTED SIZE 5 L
• Common Device Name: FEMUR STD CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; CH 6874
• MDR Report Key: 10222797
• Report Number: 3005180920-2020-00363
• Device Sequence Number: 536101
• Product Code: JWH
• UDI-Device Identifier: 07630030820236
• UDI-Public: 07630030820236
• 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: 2010
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/02/2020

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: 05/31/2014
• Device Model Number: 02.07.2005L
• Device Catalogue Number: 02.07.2005L
• Device Lot Number: 091256
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2020
• Initial Report FDA Received Date: 07/02/2020
• 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
• Patient Age: 72 YR
• Patient Weight: 98