MAUDE Adverse Event Report: CORIN LTD TRINITY; ACETBULAR SYSTEM WITH HXLPE LINERS

Model Number	104.3605
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	11/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Trinity revision of the cup, biolox delta ceramic liner and head after approximately 3 years and 9 months due to dislocation.Please note: the trinity biolox delta ceramic liner subject of this report is not cleared for sale or distribution in the usa and this event occured outside of the usa.A trinity cup and biolox delta ceramic head were also revised, these devices are cleared for sale/ distribution in the usa.
Additional Manufacturer Narrative
Per comp (b)(4) initial report, additional information including: confirmation of the device details, post primary and pre revision x-rays, operative notes (primary and revision), patient weight, activity level and medical history, did the patient follow correct post-op protocol? what was the patient doing at the time of the dislocations? did the patient experience any slips / falls or other trauma post 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.Upon the receipt of the appropriate device details, 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 revision of the cup, biolox delta ceramic liner and head after approximately 3 years and 9 months due to dislocation.Please note: the trinity biolox delta ceramic liner subject of this report is not cleared for sale or distribution in the usa and this event occured outside of the usa.A trinity cup and biolox delta ceramic head were also revised, these devices are cleared for sale/ distribution in the usa.
Additional Manufacturer Narrative
Per comp 1539 final report additional information including: confirmation of the device details post primary and pre revision x-rays operative notes (primary and revision) patient weight, activity level and medical history did the patient follow correct post-op protocol? what was the patient doing at the time of the dislocations? did the patient experience any slips / falls or other trauma post primary surgery? an update on the patient post revision has been requested in order to progress with the investigation of this event, however the reporter confirmed that none of the additional information could be provided.The device details were identified using the initial usage information.All parts associated with these records conformed to material and dimensional specification at the time of manufacture.Based on the available information, no further investigation can be conducted and the root cause of the reported dislocation could not be determined.Therefore, this case is now considered closed, however should any additional information be provided then this case may be re-opened.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: ACETBULAR SYSTEM WITH HXLPE 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: 23827218
• Report Number: 9614209-2025-00631
• Device Sequence Number: 8954738
• Product Code: LZO
• UDI-Device Identifier: 05055196964389
• UDI-Public: 05055196964389
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K110087
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2026

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 Expiration Date: 03/24/2022
• Device Model Number: 104.3605
• Device Catalogue Number: N/A
• Device Lot Number: 357093
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2025
• Supplement Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/29/2017
• 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 LINER: 321.04.436, 455642; TRINITY BIOLOX DELTA CERAMIC LINER: 321.04.436,TBC; TRINITY SHELL: 321.04.358, 449345; TRINITY SHELL: 321.04.358, TBC
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown