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

Model Number	02.07.2006R
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	10/25/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 03 november 2022: lot 130272: (b)(4) items manufactured and released on 28-mar-2013.Expiration date: 2018-02-28.No anomalies found related to the problem.To date, all the items of the same lot have been sold without any similar reported event in the period of review.Other implants involved: batch review performed on 03 november 2022 on gmk-primary 02.07.1205r tibial tray fixed cemented size 5 r (k090988) lot.140931 lot 140931: (b)(4) items manufactured and released on 14-may-2014.Expiration date: 2019-03-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.Batch review performed on 03 november 2022 on gmk-primary 02.07.0510sf tibial insert std fixed size 5 / 10 mm (k090988) lot.135560 lot 135560: (b)(4) items manufactured and released on 16-jan-2014.Expiration date: 2018-11-30.No anomalies found related to the problem.To date, all the items of the same lot have been sold without any similar reported event in the period of review.
Event or Problem Description
The patient came in reporting pain and instability.X-rays showed a recessed tibial component.At about 8 years and 4 months after primary surgery the surgeon revised all components and the surgery was completed successfully.

• Brand Name: GMK-PRIMARY FEMUR STD CEMENTED SIZE 6 R
• Common Device Name: KNEE CEMENTED FEMORAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 15778707
• Report Number: 3005180920-2022-00852
• Device Sequence Number: 14670868
• Product Code: JWH
• UDI-Device Identifier: 07630030820267
• UDI-Public: 07630030820267
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2022
• 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): 11/11/2022

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: 02/28/2018
• Device Model Number: 02.07.2006R
• Device Catalogue Number: 02.07.2006R
• Device Lot Number: 130272
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2022
• Initial Report FDA Received Date: 11/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/28/2013
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male