MAUDE Adverse Event Report: Corin Ltd Trinity; Liner (ECiMa) Ø36mm Neutral Offset Taper Size 4

Model Number	322.04.636
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/14/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Trinity / metafix collared revision of the cup, 2 screws, ecima liner, biolox delta ceramic head and collared stem after approximately 2 years and 7 months due to infection.Note: the metafix stem 579.2101 is not cleared in the usa.
Additional Manufacturer Narrative
Per (b)(4) - initial report additional information, including if there are other patient information, operative notes, x-rays, did the patient follow correct post-op protocol, has the patient undergone any recent procedure/treatments that may have caused the reported infection, if signs of metallosis and update of the patient post revision, has been requested in order to progress with the investigation of this event.Available information will be detailed in a supplemental report.The appropriate device details have been requested.The relevant device manufacturing records will be identified and reviewed.Conclusions will be provided in a supplemental report.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 occured 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: Liner (ECiMa) Ø36mm Neutral Offset Taper Size 4
• 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: 50942691
• Report Number: 9614209-2026-00129
• Device Sequence Number: 9498773
• Product Code: OQI
• UDI-Device Identifier: 05055343869574
• UDI-Public: 05055343869574
• 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: 2024
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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: 322.04.636
• Device Catalogue Number: Not applicable
• Device Lot Number: 545481
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/03/2023
• 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: Bolox Delta / Ceramic head: 104.3600 Lot 533317; Metafix / Stem: 579.2101 Lot 513039; Trinity / Cup: 321.04.356 Lot 537532; Trinity / Screw: 321.035 Lot 543761; Trinity / Screw: 321.040 Lot 528517
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male