MAUDE Adverse Event Report: CORIN MEDICAL TRINITY; ACETABULAR HIP SYSTEM WITH ECIMA LINERS

Model Number 322.02.632

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/04/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4) initial report.Post primay and pre revision x-rays, operative notes, patient details, patient medical history and the return of the explanted devices 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.The appropriate device details 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.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 5 years and 7 months due to reported liner fracture.The liner and the head were revised.

Manufacturer Narrative

(b)(4) final report.Additional information, including operative notes, x-rays, patient details and the explanted device were requested in order to progress with the investigation of this event, however, not all were provided and thus the investigation of this event was limited.The reported device was manufactured in aug 2018 as part of a batch of 30 and conformed to the correct specifications at the time of manufacture.Based on the available information, no further investigation can be conducted and the root cause of the reported dislocation could not be identified.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

This report is being submitted as a follow-up due to the information provided in the initial report being incorrect.The information provided in 9614209-2019-00037 was the information for a different event for this same patient.Please refer to 9614209-2019-00088 for the investigation of that event.Information provided in 9614209-2019-00037 initial report should be replaced with the information provided in this report.Trinity revision of the ecima liner after 2 months and 12 days due to dislocation.

Manufacturer Narrative

Per -2082 final report.Additional information, including operative notes, x-rays, patient details and the explanted device were requested in order to progress with the investigation of this event, however, not all were provided and thus the investigation of this event was limited.The reported device was manufactured in aug 2018 as part of a batch of (b)(4) and conformed to the correct specifications at the time of manufacture.Based on the available information, no further investigation can be conducted and the root cause of the reported disclocation could not be identified.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 of the ecima liner after 2 months and 12 days due to dislocation.Please note: the details provided in the initial report for this event were incorrect.The details provided in the initial fda report were for another revision event for this patient.This other revision was reported under the reference 9614209-2019-00088.All details in the initial report have been amended and it will be re-submitted.

• 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 Key: 8644819
• MDR Text Key: 146211843
• Report Number: 9614209-2019-00037
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• PMA/PMN Number: K111481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/30/2020

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 Expiration Date: 02/01/2018
• Device Model Number: 322.02.632
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 398843
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/30/2019
• Initial Date FDA Received: 05/28/2019
• Supplement Dates Manufacturer Received: 04/30/2019; 04/30/2019
• Supplement Dates FDA Received: 01/30/2020; 01/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TRINITY CUP - 321.02.348, 245588; TRINITY CUP - 321.02.348, 245588
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 54 YR