TRINITY
Received Feb 13, 2024 · Event occurred Sep 28, 2023
Report 9614209-2024-00294 · MDR key 18700018
Device
Generic name
Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented
Manufacturer
Corin MedicalModel number
E321.128Catalog number
NOT APPLICABLE
Lot number
536967
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
89 YR · Male
- Unspecified Infection
- Unspecified Infection
Narrative
Description of Event or Problem
TRINITY / MOBILIT REVISION AFTER APPROXIMATIVELY 2 WEEKS DUE TO INFECTION.
Additional Manufacturer Narrative
(B)(4) - FINAL REPORT. ADDITIONAL INFORMATION REQUESTED WAS PROVIDED. 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 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. AS THE SURGEON CONFIRMED THAT THE LINK BETWEEN THE DEVICES AND THE EVENT IS UNLIKELY AND PROBABLY DUE TO THE PROCEDURE, THE ROOT CAUSE IS CONSIDERED AS EXTERNAL. 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.
Additional Manufacturer Narrative
CASE (B)(4). INITIAL REPORT ADDITIONAL INFORMATION, INCLUDING PART NUMBER AND LOT CODE OF THE INSERT, OPERATIVE NOTES, MEDICAL HISTORY OF THE PATIENT, HAVE BEEN REQUESTED TO THE REPORTER. AVAILABLE INFORMATION WILL BE DETAILED IN A SUPPLEMENTAL REPORT. 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 / MOBILIT REVISION AFTER APPROXIMATIVELY 2 WEEKS DUE TO INFECTION.