MAUDE Adverse Event Report: CORIN LTD TRINITY DUAL MOBILITY; COCR LINER SIZE 3

Model Number	321.03.536
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/15/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Per (b)(4) - initial report.Additional information, including operative notes, x-rays, patient information, if there were any signs of impingement and if there is a confirmation of metallosis, has been requested in order to progress with the investigation of this event.Available information will be detailed in a supplemental report.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 experience 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 consititute an admission that the device, reporting entity, entity's representative or distributor caused or contributed to this event.
Event or Problem Description
Trinity dual mobility (ops used in primary) revision of the cocr liner, ecima insert and biolox delta ceramic head after approximately 1 year and 11 months due to infection with suspicion of metallosis.Note: late report due to the reporter informing vigilance late.Reporter made aware on (b)(6) 2026 but did not submit to vigilance until (b)(6) 2026.

• Brand Name: TRINITY DUAL MOBILITY
• Common Device Name: COCR LINER 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: 25764003
• Report Number: 9614209-2026-00078
• Device Sequence Number: 18588841
• Product Code: LZO
• UDI-Device Identifier: 05055343893227
• UDI-Public: 05055343893227
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K170359
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/09/2026

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: 321.03.536
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 545950
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 07/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 104.2805 LOT 540243; OPS ACETABULAR GUIDE: 1248-0500, CAR_MS_74382; OPS FEMORAL GUIDE, 1250-0100, CAR_MS_74382; TRINITY DM / INSERT: 325.03.040 LOT 548023
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 68 YR
• Patient Sex: Female