MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY FEMUR STD CEMENTED SIZE 3 R; CEMENTED FEMUR

Catalog Number	02.07.2003R
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	11/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 16-nov-2023 lot 111212: (b)(4) items manufactured and released on 08-aug-2011.Expiration date: 2016-06-30.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported case during the period of the review.Additional items involved in the complaints, batch review performed on 20 november 2023: gmk-primary 02.07.0217sf tibial insert std fixed size 2 / 17 mm (k090988) lot.101410 lot 101410: (b)(4) items manufactured and released on 09-jun-2010.Expiration date: 2015-04-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.Gmk-primary 02.07.1202r tibial tray fixed cemented size 2 r (k090988) lot.112613 lot 112613: (b)(4) items manufactured and released on 18-oct-2011.Expiration date: 2016-09-30.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported case during the period of review.
Event or Problem Description
At about 11 years and 9 months after primary, the patient came in reporting instability due to laxity.The surgeon revised the gmk primary femoral component, insert and tibial tray and converted the patient to a hinge knee and the case was completed successfully.

• Brand Name: GMK-PRIMARY FEMUR STD CEMENTED SIZE 3 R
• Common Device Name: CEMENTED FEMUR
• 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: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 18281396
• Report Number: 3005180920-2023-00987
• Device Sequence Number: 20385141
• Product Code: JWH
• UDI-Device Identifier: 07630040720243
• UDI-Public: 07630040720243
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K173794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/06/2023

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 Catalogue Number: 02.07.2003R
• Device Lot Number: 111212
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2023
• Initial Report FDA Received Date: 12/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/08/2011
• 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: Female