MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY FEMUR CEMENTED PS SIZE 3NARROW / RIGHT; KNEE FEMORAL COMPONENT

Catalog Number 02.07.2213R

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Implant Pain (4561)

Event Date 07/12/2023

Event Type  Injury  

Event Description

At about 3 years and 11 months from the primary, the patient came in reporting pain due to a femur that was too internally rotated and caused the patella bone subluxation.The surgeon revised the medacta femur and insert.The surgery was completed successfully.

Manufacturer Narrative

Batch review performed on 24-jul-2023: lot 184096: (b)(4) items manufactured and released on 25-sept-2018.Expiration date: 2023-09-11.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.

• Brand Name: GMK-PRIMARY FEMUR CEMENTED PS SIZE 3NARROW / RIGHT
• Type of Device: KNEE 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: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 17404477
• MDR Text Key: 319843908
• Report Number: 3005180920-2023-00623
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 07630030820977
• UDI-Public: 07630030820977
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122232
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/11/2023
• Device Catalogue Number: 02.07.2213R
• Device Lot Number: 184096
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/12/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/25/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male