MAUDE Adverse Event Report: FH INDUSTRIE ESOP; ESOP STEM HA METAPHYSIS 135°12/14 LEFT S11,25

Catalog Number 265346

Device Problem Fracture (1260)

Patient Problem Implant Pain (4561)

Event Date 07/21/2010

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

Stem fracture.Mhra investigation into the high number of esop replacements.

• Brand Name: ESOP
• Type of Device: ESOP STEM HA METAPHYSIS 135°12/14 LEFT S11,25
• 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 novel; quimper, 29000 ; FR 29000
• MDR Report Key: 17949039
• MDR Text Key: 325832370
• Report Number: 3003898228-2023-00014
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 03661489653469
• UDI-Public: 03661489653469
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K021108
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 10/12/2023

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: 03/31/2014
• Device Catalogue Number: 265346
• Device Lot Number: 802432
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2009
• 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 Sex: Female