MAUDE Adverse Event Report: CORIN LTD TRINITY; ACETABULAR HIP SYSTEM WITH ECIMA LINERS

Model Number	322.04.636
Medical Device Problem Codes	Loss of Osseointegration (2408); Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	03/05/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Per (b)(4) initial report: additional information including: which of the revised devices was loose? did the patient present with any symptoms like pain, change in gait or was this identified during a routine check up pre-revision and post primary x-rays operative notes (primary and revision) patient activity level, weight and medical history did the patient follow the correct post-op protocol? did the patient experience any slips / falls or other trauma post primary surgery? were there any fixation concerns during the primary surgery? 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 relevant device manufacturing records will be identified and reviewed.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 constitute an admission that the device, reporting entity, entity's representative or distributor caused or contributed to this event.
Event or Problem Description
Trinity revision (ops used in primary) of the ecima liner and biolox delta ceramic head after approximately 4 months due to loosening.
Event or Problem Description
Trinity revision (ops used in primary) of the ecima liner and biolox delta ceramic head after approximately 4 months due to loosening.
Additional Manufacturer Narrative
Per comp (b)(4) final report: additional information including: - which of the revised devices was loose? - did the patient present with any symptoms like pain, change in gait or was this identified during a routine check up.- pre-revision and post primary x-rays.- operative notes (primary and revision).- patient activity level, weight and medical history.- did the patient follow the correct post-op protocol? - did the patient experience any slips / falls or other trauma post primary surgery? - were there any fixation concerns during the primary surgery? - an update on the patient post revision.Has been requested in order to progress with the investigation of this event, however none of this information was provided.The relevant device manufacturing records will be identified and reviewed.All finished parts associated with these records conformed to material and dimensional specification at the time of manufacture.Ops was used in the primary surgery.A review of product history records was performed which revealed that no anomalies were observed in the device history records of ops insight, ops acetabular and ops femoral guide, which may have caused or contributed to this event.The ops insight plan was made in accordance with specification.There is no indication that ops would have contributed to this event.Based on the provided information, the root cause could not be determined and thus this case is considered closed.However, should any additional information be provided then this case may be re-opened for further investigation.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 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: 24713170
• Report Number: 9614209-2026-00041
• Device Sequence Number: 20274510
• Product Code: OQI
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2026

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: N/A
• Device Lot Number: 598548
• 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: 03/18/2026
• Supplement Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 06/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/11/2025
• 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: OPS ACETABULAR GUIDE: 1248-0500, WPL_BX_35602.; OPS ACETABULAR GUIDE: 1248-0500, WPL_BX_35602.; OPS FEMORAL GUIDE: 1250-0100, WPL_BX_35602.; OPS FEMORAL GUIDE: 1250-0100, WPL_BX_35602.; OPSINSIGHT: 1200-0000, WPL_BX_35602.; OPSINSIGHT: 1200-0000, WPL_BX_35602.; TRINITY BIOLOX DELTA CERAMIC HEAD: 104.3610,599635.; TRINITY BIOLOX DELTA CERAMIC HEAD: 104.3610,599635.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown