MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY FEMUR PS CEMENTED SIZE 7 R; FEMORAL COMPONENT CEMENTED

Catalog Number	02.07.2207R
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs director: total knee revision occurred 6 months after implantation of a cemented tkr.No evidence of implant defects or malposition is visible in the radiographic images provided.According to the report the patient was complaining about pain and stiffness.The cause of this problem may be due to soft tissue tension or scar tissue formation.There is no reason to suspect intrinsic defects of the devices.Batch review performed on 27 may 2019: lot 145558: (b)(4) items manufactured and released on 13-jan-2015.Expiration date: 2019-10-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Additional implants involved in the complaint: gmk-primary 02.07.1206r tibial tray fixed cemented size 6 r (k090988) lot 180251: (b)(4) items manufactured and released on 17-may-2018.Expiration date: 2023-05-06.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Gmk-primary 02.07.0612psf tibial insert ps fixed size 6/12mm (k090988) lot.154044: (b)(4) items manufactured and released on 14-dec-2015.Expiration date: 2020-11-25.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
The patient came in, 6 months after primary surgery, complaining of pain and stiffness in the knee and the cause of pain and stiffness is unknown.The surgeon revised the femoral component, tibial tray and poly and the surgery was completed successfully.

• Brand Name: GMK-PRIMARY FEMUR PS CEMENTED SIZE 7 R
• Common Device Name: FEMORAL COMPONENT CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8649833
• Report Number: 3005180920-2019-00421
• Device Sequence Number: 14043191
• Product Code: JWH
• UDI-Device Identifier: 07630030820915
• UDI-Public: 07630030820915
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K120790
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 05/29/2019

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: 10/31/2019
• Device Catalogue Number: 02.07.2207R
• Device Lot Number: 145558
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2019
• Initial Report FDA Received Date: 05/29/2019
• 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