MAUDE Adverse Event Report: CORIN LTD TRINITY; LINER (ECIMA) Ø36MM NEUTRAL OFFSET TAPER SIZE 3

Model Number	322.03.636
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	06/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Trinity revision of the ecima liner and biolox delta ceramic head after approximately 2 months due to pain and irritation.
Additional Manufacturer Narrative
(b)(4) - initial report.Additional information including post primary and pre revision x-rays, operative notes (primary and revision), patient medical history, whether the patient followed correct post-op protocol, is it suspected that the irritation was caused by an infection, 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 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 simiar 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 the reported event.
Event or Problem Description
Trinity revision of the ecima liner and biolox delta ceramic head after approximately 2 months due to pain and irritation.
Additional Manufacturer Narrative
Per (b)(4) - final report.Additional information including post primary and pre revision x-rays, operative notes (primary and revision), patient medical history, whether the patient followed correct post-op protocol, is it suspected that the irritation was caused by an infection, has been requested in order to progress with the investigation of this event.However, the reporter was not able to provide us these documents.The appropriate devices details have been provided and the relevant device manufacturing and sterilisation records have been identified and reviewed.The devices were manufactured, packaged and sterilised according to specifications at the time of manufacture.Review of these records revealed no product non-conformity or deviation from process that would have caused or contributed to the reported event.No additional information has been provided.Based on this, no further investigation can be conducted, and the root cause of the pain / irritation could not be determined.Corin now considers this case 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 the reported event.

• Brand Name: TRINITY
• Common Device Name: LINER (ECIMA) Ø36MM NEUTRAL OFFSET 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: 22156353
• Report Number: 9614209-2025-00514
• Device Sequence Number: 7266007
• Product Code: OQI
• UDI-Device Identifier: 05055343869550
• UDI-Public: 05055343869550
• 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: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2025

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 Model Number: 322.03.636
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 585429
• 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: 06/01/2025
• Supplement Date Received by Manufacturer: 06/01/2025
• Initial Report FDA Received Date: 06/06/2025
• Supplement Report FDA Received Date: 08/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/22/2025
• 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: 104.3605 LOT 586093.; BIOLOX DELTA / CERAMIC HEAD: 104.3605 LOT 586093.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female