MAUDE Adverse Event Report: FH INDUSTRIE ESOP; STEM ESOP HA DIAPHYSIS

Catalog Number 201125

Device Problem Material Fragmentation (1261)

Patient Problem Pain (1994)

Event Date 02/15/2018

Event Type  Injury  

Event Description

The patient felt the hip prosthesis break while she was in position standing.Surgery: change of his femoral stem and right femur osteosynthesis on (b)(6) 2018.

• Brand Name: ESOP
• Type of Device: STEM ESOP HA DIAPHYSIS
• 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: jean marc idier ; 3 rue de la forêt; heimsbrunn, 68990 ; FR 68990
• MDR Report Key: 7705672
• MDR Text Key: 114538458
• Report Number: 3003898228-2018-00009
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K021108
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 201125
• Device Lot Number: 9106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2018
• Date Manufacturer Received: 03/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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