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U.S. Department of Health and Human Services

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

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CORIN MEDICAL TRINITY PLUS ACETABULAR HIP SYSTEM WITH ECIMA LINERS Back to Search Results
Model Number 324.03.550
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/10/2019
Event Type  Injury  
Manufacturer Narrative
Per -2547 initial report. Post primary and pre revision x-rays, operative notes, patient medical history, an update on the patient following revision and pre-operative planning documents have been requested in order to progress with the investigation of this event, however, not all could be provided and thus the investigation of this event is limited. It was reported that the explanted devices were not available to return for examination as part of this investigation. 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.
 
Event Description
Trinity revision within 1 month due to cup loosening. The exact date of revision is unknown, but was sometime in (b)(6) 2019.
 
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Brand NameTRINITY PLUS
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
franck didier
the corinium centre
cirencester
gloucestershire, GL7 1-YJ
UK   GL7 1YJ
MDR Report Key9382958
MDR Text Key168440780
Report Number9614209-2019-00119
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 03/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/27/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number324.03.550
Device Catalogue NumberNOT APPLICABLE
Device Lot Number399580
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 Received10/29/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/04/2019
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: 11/27/2019 Patient Sequence Number: 1
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