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U.S. Department of Health and Human Services

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

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FH INDUSTRIE ESOP HA DIAPHYSIS STEM DIA11 Back to Search Results
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.
 
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Brand NameESOP HA
Type of DeviceDIAPHYSIS 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 Key6581089
MDR Text Key177369199
Report Number3003898228-2016-00013
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K021108
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received05/22/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other Health Care Professional
Device Catalogue Number233633 201119
Device Lot NumberF01504 RG01857
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/12/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/13/2016
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

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