MAUDE Adverse Event Report: CORIN LTD TRINITY EVO; CUP 58MM HOLES COATED

Model Number	BO76.3242.000.00
Medical Device Problem Codes	Osseointegration Problem (3003); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Joint Dislocation (2374); Inadequate Osseointegration (2646)
Date of Event	05/27/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Per (b)(4) - initial report.Additional information, including x-rays, operative notes, patient medical information, if patient experienced any trauma, if insert and head have been explanted and lot codes of the screws, has already been requested in order to progress with the investigation of this event.The appropriate device details have been requested 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 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.
Event or Problem Description
Trinity evo revision of the cup after approximatively 3 months and 2 weeks due to loosening.Note: the explanted part bo76.3242.000.00 is the reference registered in europe.The similar product cleared in the usa is referenced co76.3242.000.00.
Additional Manufacturer Narrative
(b)(4)- final report additional information has been communicated in order to progress with the investigation of this event.The appropriate devices details have been provided and the relevant device manufacturing records have been identified and reviewed.The devices were manufactured according to specifications at the time of manufacture.Based on the conclusions following investigation conducted by the legal manufacturer, it was determined that, although the plate and the acetabular component were positioned correctly, they were not the most appropriate choice for the defect being treated.The report also states that the fixation of the acetabular component was inadequate, as no screws were implanted in the acetabulum to provide supplementary fixation.The early failure of the construct, which occurred approximately three months after implantation, is considered indicative of insufficient primary stability of the implant and is attributable to surgical decision-making and implantation technique rather than to a deficiency or malfunction of the device itself.Based on the above, no causal relationship between the device and the reported adverse event could be established.Corin now consider 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 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 EVO
• Common Device Name: CUP 58MM HOLES COATED
• 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 GL71Y-J ; UK GL71YJ
• MDR Report Key: 25744312
• Report Number: 9614209-2026-00076
• Device Sequence Number: 18702753
• Product Code: LPH
• UDI-Device Identifier: 05056139248788
• UDI-Public: 05056139248788
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K242744
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Operator of Device: Health Professional
• Device Model Number: BO76.3242.000.00
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 2023361/001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/08/2026
• Supplement Report FDA Received Date: 09/24/2026
• 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: Trinity / Head: E321.236 Lot 602653; Trinity / Insert: 321.04.636 Lot 602918
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 171 LB