• 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 TRINITY ACETABULAR HIP SYSTEM WITH ECIMA LINERS

  • 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 TRINITY ACETABULAR HIP SYSTEM WITH ECIMA LINERS Back to Search Results
Model Number 322.03.936
Device Problems Break (1069); Fracture (1260); Unintended Movement (3026); Insufficient Information (3190); Noise, Audible (3273)
Patient Problems Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/13/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4) initial report. Corin are in the process of attempting to obtain additional information to aid the investigation of this event, and if received, will be provided in a supplemental report upon completion of the investigation. It is unknown at this time which, if any, of the explanted devices are available to return for examination. The appropriate device details have been provided and the relevant device manufacturing records will be identified and reviewed. Please note: this report is filed with the fda due to an adverse event experienced with a device that is similar to those placed on the market in the usa, however, this event occurred outside of the usa.
 
Event Description
Patient had primary surgery of the left hip on (b)(6) 2015. Patient then had a partial revision on (b)(6) 2016 due to pain and noise when sitting. A second revision was performed on (b)(6) 2017 due to the pe liner moving and being broken in multiple places. A third event then occurred on (b)(6) 2019 which was a reported stem fracture. Corin were originally aware of the stem fracture event on 01 dec 2016 and this event was reported under report reference 9614209-2016-00163. Corin received additional information relating to this patient and the previous revisions on 23 nov 2020 and thus this new initial report is being sent.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameTRINITY
Type of DeviceACETABULAR HIP SYSTEM WITH ECIMA LINERS
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
marie-anne euzen
the corinium centre
cirencester, gloucestershire GL7 1-YJ
UK   GL7 1YJ
MDR Report Key11027685
MDR Text Key222050140
Report Number9614209-2020-00130
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K111481
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/12/2019
Device Model Number322.03.936
Device Catalogue NumberNOT APPLICABLE
Device Lot Number303361
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 Received11/23/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/15/2014
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: 12/17/2020 Patient Sequence Number: 1
Treatment
METAFIX STEM - 579.0002, 298368; TRINITY CUP - 321.03.354, 293149; TRINITY MODULAR HEAD - E321.236, 305344
-
-