MAUDE Adverse Event Report: CORIN LTD TRINITY; TRINITY LINER IMPACTOR HEAD

Model Number 921.036

Device Problem Fracture (1260)

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

Event Date 04/02/2023

Event Type  malfunction  

Manufacturer Narrative

Case (b)(4) initial report additional information including; were all the ceramic liner parts that fractured retrieved, was the liner impactor aligned correctly before impaction, was the crack on the liner impactor noticed before impaction and if these devices available for return 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

Trinity liner impactor had a crack on the device before impaction and once impacted it caused the ceramic liner to fracture.This caused a surgical delay of 30 minutes.Please note: the associated trinity biolox delta ceramic liner is not cleared for sale or distribution within the usa and this event occurred outside of the usa.

Manufacturer Narrative

(b)(4) final report additional information including; were all the ceramic liner parts that fractured retrieved, was the liner impactor aligned correctly before impaction, was the crack on the liner impactor noticed before impaction and if these devices available for return has been requested.No answer was received, therefore the scope of the investigation was limited.The trinity liner impactor device details were identified and the appropriate manufacturing records were identified and reviewed.Parts were manufactured between (b)(6) 2021 and (b)(6) 2022 and conformed to dimensional and material specifications at the time of manufacture.The device's failure was confirmed from the reporter's photo.This failure has been reported in the past and an internal project was raised to search for a new device design.The project is ongoing.Based on this, the root cause of the trinity liner impactor head is device design 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.Please note: the associated trinity biolox delta ceramic liner is not cleared for sale or distribution within the usa and this event occurred outside of the usa.

• Brand Name: TRINITY
• Type of Device: TRINITY LINER IMPACTOR HEAD
• 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: 16690306
• MDR Text Key: 312792001
• Report Number: 9614209-2023-00176
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K093472
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 921.036
• Device Lot Number: 088122-37
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 04/02/2023
• Initial Date Manufacturer Received: 04/02/2023
• Initial Date FDA Received: 04/06/2023
• Supplement Dates Manufacturer Received: 04/02/2023
• Supplement Dates FDA Received: 01/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: BILOX DELTA CERAMIC LINER 321.03.436, 523308
• Patient Outcome(s): Hospitalization