MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY FEMUR PS CEMENTED SIZE 5 R; KNEE FEMUR COMPONENT CEMENTED

Catalog Number	02.07.2205R
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/02/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs department: late infection in cemented tka, 4.9 years after primary operation in a patient with several comorbidities.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.Batch review performed on 25 march 2019: lot 101731: (b)(4) items manufactured and released on 21-jul-2010.Expiration date: 2015-06-30.No anomalies found related to the problem.To date, all the items of the same lot have been already sold without any similar reported event.Other devices were involved in the complaint: gmk-primary 02.07.1204r tibial tray fixed cemented size 4 r lot 140173 (k090988): (b)(4) items manufactured and released on 25-mar-2014.Expiration date: 2019-02-28.No anomalies found related to the problem.To date, all the items of the same lot have been already sold without any similar reported event.Gmk-primary 02.07.0412psf tibial insert ps fixed size 4/12mm lot 121580 (k090988): (b)(4) items manufactured and released on 04-sep-2012.Expiration date: 2017-06-30.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
On february 28 2019 we were informed about a revision surgery performed on (b)(6), 4 years and 9 months after primary surgery, due to an infection (4 to 5 multiresistant germinations: streptococcus).During surgery, the surgeon took the liner out and noticed the tibia implant is loose.It was not foreseeable on the x-rays and the patient has no pain because his toes have been amputated and he is in a wheelchair.

• Brand Name: GMK-PRIMARY FEMUR PS CEMENTED SIZE 5 R
• Common Device Name: KNEE FEMUR COMPONENT CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8464673
• Report Number: 3005180920-2019-00207
• Device Sequence Number: 1341119
• Product Code: JWH
• UDI-Device Identifier: 07630030820878
• UDI-Public: 07630030820878
• 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: 2014
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/29/2019

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: 06/30/2015
• Device Catalogue Number: 02.07.2205R
• Device Lot Number: 101731
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2019
• Initial Report FDA Received Date: 03/29/2019
• 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
• Patient Age: 69 YR
• Patient Weight: 75