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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 Problems Device Dislodged or Dislocated (2923); Appropriate Term/Code Not Available (3191)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/25/2019
Event Type  Injury  
Manufacturer Narrative
Per 2622 initial report.In order to progress with the investigation of this event, operative notes, patient details and an update on the patient following revision has been requested, however, this information is not available and thus the investigation of this event is limited.A post primary x-ray has been provided and will be reviewed at corin.It has been confirmed that the explants will not be returned 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 cup, head and liner after approximately 4 months due to dislocation.
 
Manufacturer Narrative
Per (b)(4) final report: additional information including operative notes, patient details, an update on the patient following the revision and return of the explanted devices was requested in order to progress with the investigation of this event, however, this information could not be provided and thus the investigation was very limited.A post primary x-ray was provided and reviewed at corin.The appropriate device details were provided and the relevant device manufacturing records have been identified and reviewed.All finished parts associated with these records conformed to material and dimensional specification at the time of manufacture.Based on the above, no further investigation can be conducted and the root cause of the reported dislocation could not be determined and thus 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 of the head, liner and cup after approximately 4 months due to dislocation.
 
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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 Key9481412
MDR Text Key172574135
Report Number9614209-2019-00132
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 03/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number322.03.636
Device Catalogue NumberNOT APPLICABLE
Device Lot Number426510
Was Device Available for Evaluation? No
Date Manufacturer Received11/26/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
BIOLOX CERAMIC HEAD - 104.3605, 429007; BIOLOX DELTA CERAMIC HEAD - 104.3605, 429007; TRIFIT TS STEM - 694.0005, 422745; TRIFIT TS STEM - 694.0005, 422745; TRINITY CUP - 321.03.350, 424802; TRINITY CUP - 321.03.350, 424802
Patient Outcome(s) Hospitalization; Required Intervention;
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