MAUDE Adverse Event Report: CORIN LTD TRINITY; BIOLOX DELTA CERAMIC HEAD

Model Number	104.2800
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Joint Impingement (4834)
Date of Event	09/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Per (b)(4) initial report.Additional information including: post primary and pre revision x-rays, operative notes (primary and revision).Patient age, activity level, patient medical history.Did the patient follow the correct post-op protocol.Did the patient experience any slips/ falls or other trauma post primary? 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 an supplemental report upon completion of the investigation.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 experienced with a device that is similar to those placed on the market in the usa, however, this event occurred outside of the usa.
Event or Problem Description
Trinity dual mobility revision of the ecima insert and biolox delta ceramic head after approximately 6 years and 3 months due to psoas impingement.
Additional Manufacturer Narrative
Per (b)(4) final report additional information including: post primary and pre revision x-rays, operative notes (primary and revision), patient age, activity level, patient medical history, did the patient follow the correct post-op protocl, did the patient experience any slips/ falls or other trauma post primary? an update on the patient post revision.Unfortunately, no additional information has been provided and corin has not received any response to the above requests.The appropriate device details were provided and the relevant device manufacturing records have been identified and reviewed.Review of these records revealed no product non-conformity or deviation from process that would have caused or contributed to this event.Based on the available information, no further investigation can be conducted and the root cause has not been determined.Therefore, this case is now 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 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 this event.
Event or Problem Description
Trinity dual mobility revision of the ecima insert and biolox delta ceramic head after approximately 6 years and 3 months due to psoas impingement.

• Brand Name: TRINITY
• Common Device Name: BIOLOX DELTA CERAMIC HEAD
• 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: 23220441
• Report Number: 9614209-2025-00591
• Device Sequence Number: 8707361
• Product Code: LZO
• UDI-Device Identifier: 05055196964310
• UDI-Public: 05055196964310
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K103120
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2025

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 Expiration Date: 02/24/2024
• Device Model Number: 104.2800
• Device Catalogue Number: N/A
• Device Lot Number: 421937
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2025
• Supplement Date Received by Manufacturer: 09/22/2025
• Initial Report FDA Received Date: 10/06/2025
• Supplement Report FDA Received Date: 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/07/2019
• 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: TRINTIY DM ECIMA INSERT: 325.03.040, 411186; TRINTIY DM ECIMA INSERT: 325.03.040, 411186
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female