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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 Break (1069); Fracture (1260); Unintended Movement (3026); Insufficient Information (3190); Noise, Audible (3273)
Patient Problems Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/13/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4) initial report.Corin are in the process of attempting to obtain additional information to aid the investigation of this event, and if received, will be provided in a supplemental report upon completion of the investigation.It is unknown at this time which, if any, of the explanted devices are 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
Patient had primary surgery of the left hip on (b)(6) 2015.Patient then had a partial revision on (b)(6) 2016 due to pain and noise when sitting.A second revision was performed on (b)(6) 2017 due to the pe liner moving and being broken in multiple places.A third event then occurred on (b)(6) 2019 which was a reported stem fracture.Corin were originally aware of the stem fracture event on 01 dec 2016 and this event was reported under report reference 9614209-2016-00163.Corin received additional information relating to this patient and the previous revisions on 23 nov 2020 and thus this new initial report is being sent.
 
Manufacturer Narrative
Per (b)(4) final report it has been reported to corin that a patient underwent a total of three revisions since the implantation of corin devices on (b)(6) 2015.The 1st revision was of the trinity ecima liner (322.03.936, 303361) on (b)(6) 2016 due to pain and noise when sitting.During the revision it was found that the liner was broken.A new liner was implanted (device details and manufacturer unknown).The 2nd revision was on (b)(6) 2017 due to failure of the liner implanted during the 1st revision (device details and manufacturer unknown).During this second revision the trinity cup (321.03.354, 293149) and the modular head (e321.236, 305344) were also revised.An attempt was made to remove the metafix stem (579.0002, 298368) as well but it could not be removed and was left in situ.It is unknown what devices were implanted during this 2nd revision.The 3rd revision was on (b)(6) 2019 due to fracture of the meatfix stem.Corin has requested x-rays, operative notes, patient details, part nos.And lot codes for all corin devices associated with these events, whether the patient experienced any trauma prior to these revisions, an update on the patient post revision and return of the explanted devices, however, none of this information has been provided and thus the scope of the investiagtion was limited.The appropriate device details for the 4 parts implanted during the primary procedure have been 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 events 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
Patient had primary surgery of the left hip on (b)(6) 2015.Patient then had a partial revision on (b)(6) 2016 due to pain and noise when sitting.A second revision was performed on (b)(6) 2017 due to the pe liner moving and being broken in multiple places.A third event then occurred on (b)(6) 2019 which was a reported stem fracture.Corin were originally aware of the first revision event on (b)(6) 2016 and this event was reported under report reference 9614209-2016-00163.Corin received additional information relating to this event and the additional revisions on (b)(6) 2020.It has been identified that the information provided to corin previously, and in the report 9614206-2016-00163 was incorrect.Corin were originally informed that the 1st revision was for stem fracture, however, it is now known that the 1st revision event was for pain and noise when sitting due to a broken liner.The stem remained in situ during the 1st and 2nd revision.
 
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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 Key11027685
MDR Text Key222050140
Report Number9614209-2020-00130
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 07/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date03/12/2019
Device Model Number322.03.936
Device Catalogue NumberNOT APPLICABLE
Device Lot Number303361
Was Device Available for Evaluation? No
Date Manufacturer Received11/23/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
METAFIX STEM - 579.0002, 298368; METAFIX STEM: 579.0002, 298368; TRINITY COCR MODULAR HEAD: E321.236, 305344; TRINITY CUP - 321.03.354, 293149; TRINITY CUP: 321.03.354, 293149; TRINITY MODULAR HEAD - E321.236, 305344; UNKNOWN LINER; METAFIX STEM - 579.0002, 298368; TRINITY CUP - 321.03.354, 293149; TRINITY MODULAR HEAD - E321.236, 305344
Patient Outcome(s) Hospitalization; Required Intervention;
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