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

Model Number 322.04.636

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Irritability (2421)

Event Date 08/25/2023

Event Type  Injury  

Manufacturer Narrative

Case- (b)(4) initial report.Additional information including: can you expand on the neurological issues? were this experienced only after surgery? 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, biolox delta ceramic head and bone screws after approximately (b)(6) months and (b)(6) weeks, due to irritation and neurological issues.

Manufacturer Narrative

(b)(4), final report.Additional information including, more information on the reported neurological issues, whether these were experienced only after surgery, operative notes, x-rays, an update on the patient following the revision and whether or not the patient followed the correct post-op protocol was requested, however, this information could not be provided and thus the scope of the investigation was limited.The appropriate device details were provided and the relevant device manufacturing records have been identified and reviewed.All finished 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 reported irritation and neurological issues 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.

• 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: 17779111
• MDR Text Key: 323787793
• Report Number: 9614209-2023-00238
• 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: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 322.04.636
• Device Lot Number: 478903
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 08/25/2023
• Date Manufacturer Received: 08/25/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/10/2021
• 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 HEAD 104.3610, 483338; METAFIX UNCOLLARED STEM 579.0005, 207831; TRINITY BONE SCREW 321.015, 485317; TRINITY BONE SCREW 321.030, 489596; TRINITY CUP 321.04.356, 478080
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female