MAUDE Adverse Event Report: Corin Ltd Trinity; Acetabular Hip System with ECiMa Liners

Model Number	322.04.936
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/30/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Taperfit / trinity revision of all components after nearly 8 months due to infection.
Additional Manufacturer Narrative
Per (b)(4) initial report.Additional information including patient age, activity level, weight and medical history, post primary and pre-revision x-rays, operative notes (primary and revision), whether the patient experienced any slips / falls or other trauma post primary surgery, whether the patient followed correct post-op protocol, has the patient undergone any recent procedures / treatments that may have caused the reported infection and an update on the patient post revision, has been requested in order to progress with the investigation of this event, 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 and sterilisation 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.

• Brand Name: Trinity
• Common Device Name: 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: franck didier ; the corinium centre; cirencester, gloucestershire GL7 1-YJ ; UK GL7 1YJ
• MDR Report Key: 50447777
• Report Number: 9614209-2026-00106
• Device Sequence Number: 21410182
• Product Code: OQI
• UDI-Device Identifier: 05055343869871
• UDI-Public: 05055343869871
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K111481
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/26/2026

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: 322.04.936
• Device Catalogue Number: Not applicable
• Device Lot Number: 604394
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2026
• Initial Report FDA Received Date: 08/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BIOLOX Delta Ceramic Head: 104.3610, (b)(6).; TaperFit Cement Restrictor: 588.0002, (b)(6).; TaperFit Stem, 588.5002, (b)(6).; Trinity Cup: 321.04.356, (b)(6).; Trinity Screw: 321.025, (b)(6).
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male