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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 322.02.932
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem No Code Available (3191)
Event Date 09/24/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4) initial report.Additional information, including post primary and pre revision x-rays, operative notes, patient age and activity level, patient medical history and an update on the patient following the revision has been requested, and if received, will be provided in a supplemental report upon completion of the 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 after approximately 3 years and 6 months due to the liner dislodging from the cup and the ceramic head rubbing against the back of the cup.
 
Manufacturer Narrative
(b)(4).Final report additional information, including post primary and pre revision x-rays, operative notes, patient age and activity level, patient medical history and an update on the patient following the revision was requested in order to progress with the investigation of this event, however this information has not been provided and thus the scope of the investigation was limited.The explanted devices have not been returned for examination.The appropriate device details were provided 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 event 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.
 
Event Description
Trinity revision after approximately 3 years and 6 months due to the liner dislodging from the cup and the ceramic head rubbing against the back of the cup.
 
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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 Key10739745
MDR Text Key213249670
Report Number9614209-2020-00097
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,health
Type of Report Initial,Followup
Report Date 04/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/27/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date01/03/2022
Device Model Number322.02.932
Device Catalogue NumberNOT APPLICABLE
Device Lot Number349132
Date Manufacturer Received09/30/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
BIOLOX DELTA CERAMIC HEAD - 104.3205, 350082; BIOLOX DELTA CERAMIC HEAD - 104.3205, 350082; METAFIX STEM - 579.1004, 335335; METAFIX STEM - 579.1004, 335335; TRINITY CUP - 321.02.050, 347113; TRINITY CUP - 321.02.050, 347113; BIOLOX DELTA CERAMIC HEAD - 104.3205, 350082; METAFIX STEM - 579.1004, 335335; TRINITY CUP - 321.02.050, 347113
Patient Outcome(s) Hospitalization; Required Intervention;
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