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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 Malposition of Device (2616); Device Dislodged or Dislocated (2923)
Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/16/2021
Event Type  Injury  
Manufacturer Narrative
Per (b)(4) initial report.Additional information, including operative notes, patient details, whether the patient followed correct post-op protocol, what the patient was doing at the time of the dislocation and an update on the patient following the 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 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.The submission of this report does not constitute an admission that the device, reporting entity, entity's representative or distributor contributed to this event.
 
Event Description
Trinity revision of the cup and ecima liner after 1 day due to dislocation.
 
Manufacturer Narrative
Per -3919 final report.Additional information, including operative notes, patient details, whether the patient followed correct post-op protocol, what the patient was doing at the time of the dislocation and an update on the patient following the revision was requested in order to progress with the investigation of this event, however, this information could not be provided and thus the scopr of the investigation was limited.It was reported that the explanted devices could not be returned for examination.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.A post primary and pre revision x-ray were provided and it was observed that the cup had moved position and looked to have been placed in cartilage rather than bone.Based on the available information it has been concluded that the dislocation was likely to have occurred as a result of a malpositioned cup during primary surgery 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 contributed to this event.
 
Event Description
Trinity revision of the cup and ecima liner after 1 day 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 Key12065239
MDR Text Key258320216
Report Number9614209-2021-00080
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 07/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number322.03.936
Device Catalogue NumberNOT APPLICABLE
Device Lot Number461156
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/16/2021
Initial Date FDA Received06/25/2021
Supplement Dates Manufacturer Received06/16/2021
Supplement Dates FDA Received07/30/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
BIOLOX DELTA CERAMIC HEAD: 104.3600, 474692; BIOLOX DELTA CERAMIC HEAD: 104.3600, 474692; METAFIX COLLARED STEM: 579.0102, 411447; METAFIX COLLARED STEM: 579.0102, 411447; TRINITY CLUSTER SHELL: 321.03.350, 469865; TRINITY CLUSTER SHELL: 321.03.350, 469865; BIOLOX DELTA CERAMIC HEAD: 104.3600, 474692; METAFIX COLLARED STEM: 579.0102, 411447; TRINITY CLUSTER SHELL: 321.03.350, 469865
Patient Outcome(s) Hospitalization; Required Intervention;
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