• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORIN MEDICAL TRIFIT CF HIP STEM

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CORIN MEDICAL TRIFIT CF HIP STEM Back to Search Results
Model Number 6960006
Device Problems Malposition of Device (2616); Migration (4003)
Patient Problems Discomfort (2330); No Information (3190)
Event Type  Injury  
Manufacturer Narrative
(b)(4) initial report: additional information has been requested in order to progress with the investigation of this event, and if received, will be provided in a supplemental report upon completion of the investigation. Upon receipt of the appropriate device details, the relevant device manufacturing records will be identified and reviewed. The submission of this report does not constitute an admission that the device, reporting entity, entity's representative or distributor caused or contributed to this event.
 
Event Description
Trifit cf stem subsidence - patient may require a revision.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameTRIFIT CF
Type of DeviceHIP STEM
Manufacturer (Section D)
CORIN MEDICAL
the corinium centre
cirencester
gloucestershire, GL7 1 YJ
UK GL7 1YJ
Manufacturer (Section G)
CORIN MEDICAL
the corinium centre
cirencester
gloucestershire, GL7 1 YJ
UK GL7 1YJ
Manufacturer Contact
franck didier
the corinium centre
cirencester
gloucestershire, GL7 1-YJ
UK   GL7 1YJ
MDR Report Key9202530
MDR Text Key163120875
Report Number9614209-2019-00106
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K173880
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/17/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number6960006
Device Catalogue NumberNOT APPLICABLE
Device Lot Number407615
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/18/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/26/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/17/2019 Patient Sequence Number: 1
-
-