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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORIN MEDICAL TRINITY ACETABULAR HIP SYSTEM

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CORIN MEDICAL TRINITY ACETABULAR HIP SYSTEM Back to Search Results
Model Number 321.02.348
Device Problem Inaccurate Information (4051)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/29/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4) initial report. The device details were provided and the relevant device manufacturing records will be identified and reviewed. The failure mode (incorrect lot code) on the patient stickers was confirmed based on a photograph provided by the reporter. Additional was requested to the reporter, such as the lot code marked on the device, the lot code on the part blister, and if the part was implanted. 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
Trinity cluster shell - discrepancy between the lot codes on the inside and the outside labels. All other information on the labels is correct.
 
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Brand NameTRINITY ACETABULAR HIP SYSTEM
Type of DeviceTRINITY ACETABULAR HIP SYSTEM
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 Key11659774
MDR Text Key251695468
Report Number9614209-2021-00045
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K093472
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/12/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number321.02.348
Device Catalogue NumberNOT APPLICABLE
Device Lot Number427883
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received04/01/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/12/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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