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

Model Number 322.04.936

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

Patient Problem Unspecified Infection (1930)

Event Date 09/01/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4) initial report, additional information including; operative notes, x-rays (pre and post revision), an update on the patient following the revision and did the patient follow the correct post-op protocol 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 revision of ecima liner and biolox ceramic head after approximately 3 weeks due to infection.

Manufacturer Narrative

(b)(4).Final report: additional information including; operative notes, x-rays (pre and post revision), an update on the patient following the revision and did the patient follow the correct post-op protocol has been requested.No additional information were available.The appropriate explanted device details were provided and the relevant device manufacturing and sterilisation records have been identified and reviewed.Review of these records revealed no product non-conformity or deviation from process that would have caused or contributed to the reported infection.Based on the available information, no further investigation can be conducted and the root cause of the reported infection could not be identified.Infection is a known complication with any invasive surgery 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.

• Brand Name: TRINITY
• Type of Device: TRINITY ACETABULAR 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: 17841711
• MDR Text Key: 324549072
• Report Number: 9614209-2023-00245
• 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: 01/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 322.04.936
• Device Lot Number: 534969
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/01/2023
• Date Manufacturer Received: 09/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: BILOX DELTA CERAMIC HEAD 104.3610, 538336; TRINITY BONE SCREW 321.025, 517208; TRINITY CUP 321.04.354, 517381
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female