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

Model Number	321.02.932
Medical Device Problem Codes	Material Integrity Problem (2978); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Trinity revision scheduled for (b)(6) 2024 due to pain and reported poly wear.
Additional Manufacturer Narrative
Per - (b)(4) initial report additional information including whether the explants will be available for examination following the revision, post primary and pre revision x-rays, operative notes, patient activity level, medical history and weight, how long after primary surgery did the pain start, whether the patient followed correct post-op protocol and whether the patient experienced any slips / falls or other trauma post primary surgery was requested in order to progress with the investigation of this event.The reporter stated that the devices had been implanted for approximately 2 years and 9 months prior to the pain starting and that there was no apparent trauma post primary surgery.The other information could not be provided.The explanted devices will be returned to corin following the revision and will be reviewed.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 or Problem Description
Trinity revision of the shell, hxlpe liner and cocr modular head after approximately 3 years and 10 months due to pain and poly wear.Please note: the revision was originally scheduled for (b)(6) 2024, however, it has been confirmed that the revision was brought forward and was performed on (b)(6) 2024.
Additional Manufacturer Narrative
Per -6127 final report additional information including whether the explants will be available for examination following the revision, post primary and pre revision x-rays, operative notes, patient activity level, medical history and weight, how long after primary surgery did the pain start, whether the patient followed correct post-op protocol and whether the patient experienced any slips / falls or other trauma post primary surgery was requested in order to progress with the investigation of this event.The reporter stated that the devices had been implanted for approximately 2 years and 9 months prior to the pain starting and that there was no apparent trauma post primary surgery.The other information could not be provided.The explanted devices were returned and examined.Based on this review and the information provided it has been concluded that there are two possible reasons for the dislocation.Either the liner has fractured post primary surgery and subsequently has disassociated with the shell.This has resulted in the modular head articulating in the bottom of the acetabular shell.Or the liner has disassociated with the shell first, resulting in the modular head articulating in the bottom of the shell.The liner has then fractured after the disassociation.Based on what information could be provided it cannot be determined which of these events has actually occurred and thus the root cause cannot be fully determined.The appropriate device details were 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.Based on the above, no further investigation can be conducted and the root cause could not be determined.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
• Common Device Name: ACETABULAR HIP SYSTEM WITH HXLPE 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: franck didier ; the corinium centre; cirencester, gloucestershire GL7 1-YJ ; UK GL7 1YJ
• MDR Report Key: 19402860
• Report Number: 9614209-2024-00332
• Device Sequence Number: 17904789
• Product Code: LZO
• UDI-Device Identifier: 05055196971479
• UDI-Public: 05055196971479
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K110087
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/06/2026
• Device Model Number: 321.02.932
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 478862
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2024
• Supplement Date Received by Manufacturer: 05/01/2024
• Initial Report FDA Received Date: 05/28/2024
• Supplement Report FDA Received Date: 07/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/18/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: METAFIX STEM: 579.2003, 471680; METAFIX STEM: 579.2003, 471680; TRINITY COCR MODULAR HEAD: E321.032, 479472; TRINITY COCR MODULAR HEAD: E321.032, 479472; TRINITY CUP: 321.02.350, 468112; TRINITY CUP: 321.02.350, 468112
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female