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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORIN MEDICAL TRINITY ACETABULAR HIP SYSTEM WITH ECIMA LINERS

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CORIN MEDICAL TRINITY ACETABULAR HIP SYSTEM WITH ECIMA LINERS Back to Search Results
Model Number 322.04.940
Device Problem Device Dislodged or Dislocated (2923)
Patient Problems Fall (1848); Joint Dislocation (2374)
Event Date 10/12/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4) combined report. It was reported that following primary surgery the patient fell and dislocated which resulted in a closed reduction. Following this the patient had another fall and second dislocation so the surgeon decided to revise the trinity ecima liner and implant an elevated wall liner. The appropriate device details were provided and the relevant device manufacturing records have been identified and reviewed. All parts associated with these records conformed to material and dimensional specification at the time of manufacture. As the dislocation and subsequent revision was the result of the patient falling post-op, no further investigation is required and this case is now considered closed.
 
Event Description
Trinity revision of the ecima liner after 13 days due to the patient falling and dislocating.
 
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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
sean moule
the corinium centre
cirencester, gloucestershire GL7 1-YJ
UK   GL7 1YJ
MDR Report Key10778947
MDR Text Key214395444
Report Number9614209-2020-00099
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K111481
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial
Report Date 11/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number322.04.940
Device Catalogue NumberNOT APPLICABLE
Device Lot Number457056
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/13/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/17/2020
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: 11/03/2020 Patient Sequence Number: 1
Treatment
TRINITY BONE SCREW - 321.040, 417720; TRINITY BONE SCREW - 321.045, 425353
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