TRINITY
Received Oct 10, 2025 · Event occurred Oct 8, 2025
Report 9614209-2025-00593 · MDR key 23265272
Device
Generic name
Trinity Multi Hole Shell Ø52mm Taper Size 3
Manufacturer
Corin LtdModel number
321.03.352Catalog number
NOT APPLICABLE
Lot number
592145
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
72 YR · Female
- Unspecified Infection
- Unspecified Infection
Narrative
Additional Manufacturer Narrative
PER (B)(4) - FINAL REPORT. ADDITIONAL INFORMATION, INCLUDING OPERATIVE NOTES, X-RAYS AND MEDICAL HISTORY OF THE PATIENT, HAS BEEN REQUESTED IN ORDER TO PROGRESS WITH THE INVESTIGATION OF THIS EVENT. HOWEVER, THE REPORTER DOES NOT HAVE ACCESS TO ANY OF THIS INFORMATION. THE APPROPRIATE DEVICES DETAILS HAVE BEEN PROVIDED AND THE RELEVANT DEVICE MANUFACTURING AND STERILISATION RECORDS HAVE BEEN IDENTIFIED AND REVIEWED. THE DEVICES WERE MANUFACTURED, PACKAGED AND STERILISED ACCORDING TO SPECIFICATIONS AT THE TIME OF MANUFACTURE. THE CLEANING METHOD, THE STERILIZATION METHOD AND STERILE BARRIER SYSTEM USED TO PACKAGE OUR DEVICES HAVE A LONG HISTORY OF SAFE AND EFFECTIVE USE AT CORIN FOR A WIDE RANGE OF ORTHOPEDIC DEVICES AND HAS BEEN VALIDATED IN ACCORDANCE WITH THE RELEVANT STANDARDS. INFECTION IS A KNOWN COMPLICATION WITH ANY INVASIVE SURGERY. BASED ON THE ABOVE, NO FURTHER INVESTIGATION CAN BE CONDUCTED. THE ROOT CAUSE IS NOT DETERMINED. CORIN CONSIDER NOW 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.
Description of Event or Problem
TRINITY AND METAFIX REVISION OF ALL PARTS AFTER APPROXIMATIVELY 1 MONTH DUE TO INFECTION.
Additional Manufacturer Narrative
PER COMP (B)(4) - INITIAL REPORT. ADDITIONAL INFORMATION, INCLUDING OPERATIVE NOTES, X-RAYS AND MEDICAL HISTORY OF THE PATIENT, HAS BEEN REQUESTED IN ORDER TO PROGRESS WITH THE INVESTIGATION OF THIS EVENT. AVAILABLE INFORMATION WILL BE DETAILED IN A SUPPLEMENTAL REPORT. THE APPROPRIATE DEVICE DETAILS HAVE BEEN REQUESTED. 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 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.
Description of Event or Problem
TRINITY AND METAFIX REVISION OF ALL PARTS AFTER APPROXIMATIVELY 1 MONTH DUE TO INFECTION.