• 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 HXLPE LINERS TRINITY COCR MODULAR HEAD

  • 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 HXLPE LINERS TRINITY COCR MODULAR HEAD Back to Search Results
Model Number E321.236
Device Problem Inaccurate Information (4051)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/07/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4) initial report. The appropriate device details have been provided. The relevant device manufacturing records were identified and will be reviewed. One part from each of the 2 involved batches were opened and contained the correct part. It is confirmed based on photograph that the part was packaged with the incorrect labeling. Conclusions will be provided in a supplemental report. 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
A kneetec size 2 tibial tray was labeled as trinity modular head.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameTRINITY ACETABULAR HIP SYSTEM WITH HXLPE LINERS
Type of DeviceTRINITY COCR MODULAR HEAD
Manufacturer (Section D)
CORIN MEDICAL
the corinium center
cirencester, gl7 1yj
UK
Manufacturer (Section G)
CORIN MEDICAL
the corinium center
cirencester, gl7 1yj
UK
Manufacturer Contact
marie-anne euzen
the corinium center
cirencester, gl7 1yj 
UK  
MDR Report Key11816062
MDR Text Key251694181
Report Number9614209-2021-00063
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeSF
PMA/PMN Number
K110087
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 12/15/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberE321.236
Device Catalogue NumberNOT APPLICABLE
Device Lot Number408143
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/25/2021
Is the Reporter a Health Professional? No
Date Manufacturer Received05/07/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/15/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-