MAUDE Adverse Event Report: CORIN LTD TRINITY ACETABULAR HIP SYSTEM; TRINITY MULTI HOLE SHELL Ø52MM TAPER SIZE 3

Model Number	321.03.352
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Joint Impingement (4834)
Date of Event	06/01/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Per (b)(4) initial report.Additional information, including a description of the nature of the impingement that led to the revision, what was identified intra-operatively as the cause of the impingement, a post primary x-rays, operative notes (primary and revision), patient activity level, weight and medical history, whether the patient followed correct post-op protocol, if the patient experienced any slips, falls or other trauma post primary surgery and an update on the patient post revision was requested in order to progress with the investigation of this event, 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.A review of the available manufacturing records did not identify any findings that could be associated with the reported impingement.Based on the information provided, the root cause of the reported impingement 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, entities representative or distributor caused or contributed to this event.
Event or Problem Description
Trinity/trinity dual mobility revision of the cluster shell, biolox delta ceramic modular head and ecima insert after approximatively 3 years and 2 months due to impingement.

• Brand Name: TRINITY ACETABULAR HIP SYSTEM
• Common Device Name: TRINITY MULTI HOLE SHELL Ø52MM TAPER SIZE 3
• 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: 25545029
• Report Number: 9614209-2026-00066
• Device Sequence Number: 14842880
• Product Code: LWJ
• UDI-Device Identifier: 05055196927476
• UDI-Public: 05055196927476
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K093472
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/18/2026

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 Model Number: 321.03.352
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 522774
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2026
• Initial Report FDA Received Date: 06/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/03/2023
• 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: BIOLOX DELTA CERAMIC HEAD: 104.2810 LOT 524692.; TRINITY DM ECIMA LINER: 325.03.040, 522257.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female