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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORIN MEDICAL CORIN TRIFIT CF HIP STEM

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CORIN MEDICAL CORIN TRIFIT CF HIP STEM Back to Search Results
Model Number 6961007
Device Problem Inaccurate Information (4051)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/07/2021
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. It is confirmed based on photograph that the part was packaged with the incorrect labeling. Conclusions will be provided in a supplemental report.
 
Event Description
A trifit ts stem size 2 was labeled as trifit cf size 7. The failure was found during surgery and the part was discarded. Another part from the same batch was opened and contained the correct part. This part was implanted.
 
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Brand NameCORIN TRIFIT CF HIP STEM
Type of DeviceCORIN TRIFIT CF HIP STEM
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 Key11653559
MDR Text Key251693697
Report Number9614209-2021-00043
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
Remedial Action Recall
Type of Report Initial,Followup
Report Date 07/23/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number6961007
Device Catalogue NumberNOT APPLICABLE
Device Lot Number467881
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/25/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/07/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/11/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction Number87959

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