MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE FEMORAL COMPONENT SIZE 6; KNEE FEMORAL IMPLANT

Model Number 02.09.2606R

Device Problem Material Integrity Problem (2978)

Patient Problem Pain (1994)

Event Date 12/08/2020

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 18 december 2020: lot 171440: (b)(4) items manufactured and released on 24-may-2017.Expiration date: 2022-05-01.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.

Event Description

The patient came in, 1 year and 3 months after primary surgery, reporting pain and instability.X-rays revealed a fractured cement mantle proximal to the femoral stem extension and loose femoral components.The cause of the fractured cement mantle and the loose femoral components is unknown.The surgeon revised the femoral component and the surgery was completed successfully.

Manufacturer Narrative

Primary surgery date: (b)(6) 2017.Event description:the patient came in, 3 years and 3 months after primary surgery, reporting pain and instability.X-rays revealed a fractured cement mantle proximal to the femoral stem extension and loose femoral components.The cause of the fractured cement mantle and the loose femoral components is unknown.The surgeon revised the femoral component and the surgery was completed successfully.

Event Description

The patient came in, 3 years and 3 months after primary surgery, reporting pain and instability.X-rays revealed a fractured cement mantle proximal to the femoral stem extension and loose femoral components.The cause of the fractured cement mantle and the loose femoral components is unknown.The surgeon revised the femoral component and the surgery was completed successfully.

• Brand Name: GMK-HINGE FEMORAL COMPONENT SIZE 6
• Type of Device: KNEE FEMORAL IMPLANT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11106981
• MDR Text Key: 224759472
• Report Number: 3005180920-2021-00013
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 07630030825507
• UDI-Public: 07630030825507
• Combination Product (y/n): N
• PMA/PMN Number: K130299
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2022
• Device Model Number: 02.09.2606R
• Device Catalogue Number: 02.09.2606R
• Device Lot Number: 171440
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention