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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 322.03.636
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Joint Dislocation (2374)
Event Date 07/31/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4) initial report.Additional information including post primary and pre revision x-rays, operative notes, patient details, patient medical history, whether the patient experienced any trauma prior to the revision and an update on the patient post revision has been requested, however, not all information could be provided and thus the scope of this investigation is limited.It has been stated that the explanted devices are not available to return 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.
 
Event Description
Trinity revision of the ecima liner and ceramic head after approximately 2 years and 6 months due to recurrent posterior dislocation.
 
Event Description
Trinity revision of the ecima liner and ceramic head after approximately 2 years and 6 months due to recurrent posterior dislocation.
 
Manufacturer Narrative
(b)(4) final report additional information including post primary and pre revision x-rays, operative notes, patient details, patient medical history, whether the patient experienced any trauma prior to the revision and an update on the patient post revision was requested in order to progress with the investigation of this event, however, not all information could be provdied and thus the scope of this investigation is limited.It was confirmed that the explanted devices were not available to return for examination.The appropriate device details were provdied 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.Based on the available information, no further investigation can be conducted and the root cause of the reported dislocations could not be determined.Therefore, this case is now considered closed, however, should any additional information be provided then this case may be re-opened for further investigation.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 caused or contributed to this event.
 
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Brand Name
TRINITY
Type of Device
ACETABULAR HIP SYSTEM WITH ECIMA LINERS
Manufacturer (Section D)
CORIN MEDICAL
the corinium centre
cirencester, gloucestershire GL7 1 YJ
UK  GL7 1YJ
MDR Report Key11036445
MDR Text Key222298569
Report Number9614209-2020-00134
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
PMA/PMN Number
K111481
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 03/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date10/11/2022
Device Model Number322.03.636
Device Catalogue NumberNOT APPLICABLE
Device Lot Number373582
Date Manufacturer Received12/11/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
BIOLOX DELTA CERAMIC HEAD - 104.3605, 382118; BIOLOX DELTA CERAMIC HEAD - 104.3605, 382118; TRIFIT TS STEM - 694.1004, 364354; TRIFIT TS STEM - 694.1004, 364354; TRINITY CUP - 321.03.350, 374823; TRINITY CUP - 321.03.350, 374823; BIOLOX DELTA CERAMIC HEAD - 104.3605, 382118; TRIFIT TS STEM - 694.1004, 364354; TRINITY CUP - 321.03.350, 374823
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age70 YR
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