MAUDE Adverse Event Report: CORIN LTD TRIFIT TS; TRIFIT TS TAPERED STEM STANDARD SIZE 7

Model Number	694.0007
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Periprosthetic fracture (4902)
Date of Event	06/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Trifit ts / trinity dual mobility revision of the stem, ecima insert and biolox delta ceramic head after approximately 2 months due to a peri-prosthetic fracture from a fall.
Additional Manufacturer Narrative
(b)(4) initial report additional information, including post primary and pre revision x-rays, operative notes (primary and revision), patient activity level, weight and medical history, whether the patient followed correct post-op protocol, and an update on the patient post revision was requested in order to progress with the investigation of this event, however, this information could not be provided and thus the scope of the investigation was limited.The appropriate device details were provided and the relevant device manufacturing records have been identified and reviewed.A review of the available manufacturing records did not identify any findings that could be associated with the reported peri-prosthetic fracture.Based on the information provided, the root cause is determined as a patient related issue (trauma / fall) and not linked to the device design or performance.This case is now considered 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, entities representative or distributor caused or contributed to this event.

• Brand Name: TRIFIT TS
• Common Device Name: TRIFIT TS TAPERED STEM STANDARD SIZE 7
• 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: 25619666
• Report Number: 9614209-2026-00068
• Device Sequence Number: 13310735
• Product Code: KWY
• UDI-Device Identifier: 05055343877234
• UDI-Public: 05055343877234
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K121563
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/25/2026

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: 694.0007
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 594276
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2026
• Initial Report FDA Received Date: 06/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/16/2026
• 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 BIOLOX DELTA MOD HEAD: 104.2810 LOT 611613; TRINITY DM ECIMA INSERT: 325.04.042 LOT 610533
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female