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

Model Number 325.04.042

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/29/2023

Event Type  Injury  

Manufacturer Narrative

Case-(b)(4) initial report.Additional information including; aside from this issue, did the surgery proceed normally and is there any update on the patient post-surgery 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.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

Significant surgical delay due to unavailable spare trinity dual mobility ecima insert size 4 implant in the hospital.

Manufacturer Narrative

(b)(4) final report no update on the patient condition was provided.Investigation was performed and the event was the consequence of the following elements: an insert was used the night before and another insert was in stock in the hospital the part in stock was used during the reported surgery.The surgeon explanted the part immediately (for reasons external to the device in question), and a new part was required.No more part was in stock at the healthcare facility.A part was requested to be sent urgently by the manufacturer: unfortunately, the incorrect part was ordered by the field.-a part was finally successfully provided this is the only event corin is aware of where a trinity dual mobility ecima liner device was involved in an adverse event related to supply/transport issues since 2018.Extra implants have now been placed on the hospital shelves in order to prevent the reoccurrence of this event.Based on this, this is an isolated case and this case is now considered closed.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.Note: there was no device malfunction.As this is a service issue.This event was reported as a significant delay in surgery was reported.Therefore section h1/2 was corrected and device manufacturing records review was not applicable.

• Brand Name: TRINITY
• Type of Device: TRINITY HIP SYSTEM WITH ECIMA LINERS
• Manufacturer (Section D): CORIN LTD; the corinium centre; cirencester; gloucestershire GL7 1 YJ; UK GL7 1YJ
• Manufacturer (Section G): CORIN LTD; the corinium centre; cirencester; gloucestershire GL7 1 YJ; UK GL7 1YJ
• Manufacturer Contact: dardan uka ; the corinium centre; cirencester; gloucestershire GL7 1-YJ ; UK GL7 1YJ
• MDR Report Key: 17404752
• MDR Text Key: 319878139
• Report Number: 9614209-2023-00210
• Device Sequence Number: 1
• Product Code: OQI
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K111481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 325.04.042
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 06/29/2023
• Date Manufacturer Received: 06/29/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization