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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 322.04.636
Device Problems Device Dislodged or Dislocated (2923); Insufficient Information (3190)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/22/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4) initial report. Additional information, including device lot codes, part number and lot code of the associated trinity cup, date of primary surgery, post primary and pre revision x-rays, operative notes, patient details, whether the patient experienced any slips or falls post primary surgery, whether the patient followed correct post-op protocol post primary and an update on the patient post revision has been requested in order to progress with the investigation of this event, and if received, will be provided in a supplemental report upon completion of the investigation. Upon receipt of the appropriate device details, the relevant device manufacturing records will be identified and reviewed.
 
Event Description
Trinity revision of the ecima liner and modular head due to the liner being disassociated from the trinity cup.
 
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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
marie-anne euzen
the corinium centre
cirencester, gloucestershire GL7 1-YJ
UK   GL7 1YJ
MDR Report Key12743888
MDR Text Key279814554
Report Number9614209-2021-00130
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,Followup
Report Date 11/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/03/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number322.04.636
Device Catalogue NumberNOT APPLICABLE
Device Lot NumberNOT PROVIDED
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received10/27/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 11/03/2021 Patient Sequence Number: 1
Treatment
TRINITY MODULAR HEAD: E321.036, LOT CODE UNKNOWN
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