MAUDE Adverse Event Report: FH INDUSTRIE ESOP HA; DIAPHYSIS STEM DIA11

Catalog Number 233633 201119

Device Problems Device-Device Incompatibility (2919); Compatibility Problem (2960)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/13/2016

Event Type  malfunction  

Event Description

When the diaphysis is mounted, the diaphysis is blocked on the stem after 2 turns.Place another implant with the same reference.

Event Description

When the diaphysis is mounted, the diaphysis is blocked on the stem after 2 turns.Place another implant with the same reference.

• Brand Name: ESOP HA
• Type of Device: DIAPHYSIS STEM DIA11
• Manufacturer (Section D): FH INDUSTRIE; 6 rue nobel; quimper, france 29000 ; FR 29000
• Manufacturer (Section G): FH INDUSTRIE; 6 rue nobel; quimper, france 29000 ; FR 29000
• Manufacturer Contact: ruillier ; 3 rue de la forêt; heimsbrunn, france 68990
• MDR Report Key: 6581089
• MDR Text Key: 177369199
• Report Number: 3003898228-2016-00013
• 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: distributor,health profession
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Catalogue Number: 233633 201119
• Device Lot Number: F01504 RG01857
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 60 YR