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

Catalog Number	265346
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	07/21/2010
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
Stem fracture.Mhra investigation into the high number of esop replacements.

• Brand Name: ESOP
• Common Device Name: 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
• Report Number: 3003898228-2023-00014
• Device Sequence Number: 12668347
• Product Code: MEH
• UDI-Device Identifier: 03661489653469
• UDI-Public: 03661489653469
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K021108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2010
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 10/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/31/2014
• Device Catalogue Number: 265346
• Device Lot Number: 802432
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2020
• Initial Report FDA Received Date: 10/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2009
• 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
• Patient Sex: Female