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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 Device Dislodged or Dislocated (2923); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)
Patient Problems Joint Dislocation (2374); Insufficient Information (4580)
Event Date 01/18/2022
Event Type  Injury  
Manufacturer Narrative
(b)(4). Additional information, including post primary and pre revision x-rays, operative notes (primary and revision), patient medical history, what was the patient doing at the time of the dislocation, whether patient experienced any slips / falls or other trauma prior to the dislocation, whether the patient followed correct post-op protocol, what the patient was revised to 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. It has been reported that the explanted devices are not available to return for examination. The appropriate device details were provided and the relevant device manufacturing records have been identified and reviewed. It was found that all parts associated with these records conformed to material and dimensional specification at the time of manufacture. 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 caused or contributed to this event.
 
Event Description
Trinity revision of the cup, ecima liner and ceramic head 1 day post-op 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 Key13382243
MDR Text Key284617127
Report Number9614209-2022-00007
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeAS
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
Report Date 02/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/28/2022
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 Number462873
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received01/19/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/09/2020
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: 01/28/2022 Patient Sequence Number: 1
Treatment
BIOLOX DELTA CERAMIC HEAD: 104.3605, 490413; TRINITY CUP: 321.03.352, 456933
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