MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY FEMUR STD CEMENTED SIZE 4 L; CEMENTED FEMORAL COMPONENET

Model Number	02.07.2004L
Health Effect - Clinical Code	Damage to Ligament(s) (1952)
Date of Event	07/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 28 july 2021: lot 1811521: (b)(4) items manufactured and released on 02-apr-2019.Expiration date: 2024-03-19.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Other devices involved: batch review performed on 28 july 2021: gmk-primary 02.07.0410muc tibial insert uc mobile size 4 / 10 mm (not registered in us) lot 1904282: (b)(4) items manufactured and released on 09-aug-2019.Expiration date: 2024-07-22.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Gmk-primary 02.07.1003l tibial tray mobile cemented size 3 l (not registered in us) lot 1903548: (b)(4) items manufactured and released on 18-sep-2019.Expiration date: 2024-09-04.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.
Event or Problem Description
The patient broke his medial collateral ligaments (cause is unknown) therefore the implanted prostehsis was not stable anymore.1 year and 7 months after the primary surgery, the surgeon decided to change the prosthesis to a gmk hinge.

• Brand Name: GMK-PRIMARY FEMUR STD CEMENTED SIZE 4 L
• Common Device Name: CEMENTED FEMORAL COMPONENET
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12265697
• Report Number: 3005180920-2021-00671
• Device Sequence Number: 4376735
• Product Code: JWH
• UDI-Device Identifier: 07630030820212
• UDI-Public: 07630030820212
• 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: 2019
• 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): 08/03/2021

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: 03/19/2024
• Device Model Number: 02.07.2004L
• Device Catalogue Number: 02.07.2004L
• Device Lot Number: 1811521
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2021
• Initial Report FDA Received Date: 08/03/2021
• 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: 63 YR