MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY FEMUR STD CEMENTED SIZE 6 R; CEMENTED FEMUR IMPLANT

Model Number	02.07.2006R
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 29.September.2021.Lot 111255: (b)(4) items manufactured and released on 8-jul-2011.Expiration date: 2016-06-30.No anomalies found related to the problem.To date, all items of the same lot have been sold without other similar reported events since 2017.Additional implant involved: gmk-primary 02.07.1205r tibial tray fixed cemented size 5 r (k090988) lot.100869.Batch review performed on 29.September.2021.Lot 100869: (b)(4) items manufactured and released on 11-jun-2010.Expiration date: 2015-04-30.No anomalies found related to the problem.To date, all items of the same lot have been sold without other similar reported events since 2017.Additional implant involved: gmk-primary 02.07.0514fuc tibial insert uc fixed size 5 / 14 mm (k090988) lot.102842.Batch review performed on 29.September.2021.Lot 102842: (b)(4) items manufactured and released on 22-oct-2010.Expiration date: 2015-08-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without other similar reported events since 2017.Clinical evaluation performed by medical affairs manager: late infection in cemented tka, 10 years after primary operation.Infection is a known possible adverse event following every surgery, including tka's.To date, there is no reason to suspect that the cause may be linked to the implanted devices.
Event or Problem Description
Revision surgery was performed 9 years and 11 months after the primary surgery due to infection.All implants were revised.The pathogen is unknown.

• Brand Name: GMK-PRIMARY FEMUR STD CEMENTED SIZE 6 R
• Common Device Name: CEMENTED FEMUR IMPLANT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12645636
• Report Number: 3005180920-2021-00817
• Device Sequence Number: 1454178
• Product Code: JWH
• UDI-Device Identifier: 07630030820267
• UDI-Public: 07630030820267
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/18/2021

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: 06/30/2016
• Device Model Number: 02.07.2006R
• Device Catalogue Number: 02.07.2006R
• Device Lot Number: 111255
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2021
• Initial Report FDA Received Date: 10/18/2021
• 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: 83 YR