MAUDE Adverse Event Report: FH INDUSTRIE HNG; COCR FEMORAL HEAD D28 12/14 D28 M (+0) USA

Catalog Number 268156

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Implant Pain (4561)

Event Date 11/17/2020

Event Type  malfunction  

Manufacturer Narrative

Fh industrie procedures did not clearly define the rules for reporting incidents to fda when the devices were no longer being distributed into the us market.The vigilance officer at the time was unaware that these reporting rules had to be applied even to products that were no longer distributed in the united states and that were inactivated in the fda registration & listing database.The medwatch reports that were not filed are not connected to any recalls and had no impact on patient safety.A capa was opened to determine root cause and corrective action.

Event Description

Hospitalisation in general medicine for hip pain on left prosthesis: suspected metallosis patient's current condition : hip pain.Blood chromium and cobalt levels well above normal.Pelvic x-ray revealed multiple diffuse calcified masses in the iliac psoas g muscle.Muscle biopsy revealed a black liquid.Crco total hip replacement implanted on (b)(6) 2016.Actions undertaken in the care facility for the management of the patient: scheduling at the beginning of december removal of the left hip prosthesis.The prosthesis is due to be replaced once the blood levels of chromium and cobalt have been regularised".

• Brand Name: HNG
• Type of Device: COCR FEMORAL HEAD D28 12/14 D28 M (+0) USA
• Manufacturer (Section D): FH INDUSTRIE; 6 rue nobel; quimper, 29000 ; FR 29000
• Manufacturer (Section G): FH INDUSTRIE; 6 rue nobel; quimper, 29000 ; FR 29000
• Manufacturer Contact: el yazid aribi ; 6 rue nobel; quimper, 29000 ; FR 29000
• MDR Report Key: 17948829
• MDR Text Key: 325825547
• Report Number: 3003898228-2023-00012
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K021109
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 10/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/13/2021
• Device Catalogue Number: 268156
• Device Lot Number: RG01761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/27/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2016
• 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