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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 322.03.936
Device Problems Malposition of Device (2616); Device Dislodged or Dislocated (2923)
Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/16/2021
Event Type  Injury  
Manufacturer Narrative
Per (b)(4) initial report. Additional information, including operative notes, patient details, whether the patient followed correct post-op protocol, what the patient was doing at the time of the dislocation and an update on the patient following the 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. It has been reported that the explanted devices are not available for examination. The appropriate device details have been provided and the relevant device manufacturing records will be identified and reviewed. 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. The submission of this report does not constitute an admission that the device, reporting entity, entity's representative or distributor contributed to this event.
 
Event Description
Trinity revision of the cup and ecima liner after 1 day due to dislocation.
 
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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 Key12065239
MDR Text Key258320216
Report Number9614209-2021-00080
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeAS
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 07/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/25/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number322.03.936
Device Catalogue NumberNOT APPLICABLE
Device Lot Number461156
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/16/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/01/2020
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: 06/25/2021 Patient Sequence Number: 1
Treatment
BIOLOX DELTA CERAMIC HEAD: 104.3600, 474692; METAFIX COLLARED STEM: 579.0102, 411447; TRINITY CLUSTER SHELL: 321.03.350, 469865
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