TRINITY
Received Jul 2, 2024 · Event occurred Apr 21, 2023
Report 9614209-2024-00351 · MDR key 19653230
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
75 YR · Male
- Unspecified Infection
- Unspecified Infection
Narrative
Additional Manufacturer Narrative
PER (B)(4) - INITIAL REPORT ADDITIONAL INFORMATION INCLUDING OPERATIVE NOTES AND SERIOUS ADVERSE EVENT DOCUMENTATION HAS BEEN REQUESTED IN ORDER TO PROGRESS WITH THE INVESTIGATION OF THIS EVENT AND WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. THE APPROPRIATE DEVICE DETAILS WERE PROVIDED AND THE RELEVANT DEVICE MANUFACTURING RECORDS WILL BE IDENTIFIED AND WILL BE 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.
Description of Event or Problem
MOBILIT / TRINITY REVISION OF THE PE INSERT AND MODULAR HEAD AFTER APPROXIMATELY 1 MONTH AND 2 WEEKS DUE TO STAPHYLOCOCCUS CAPITIS. PLEASE NOTE: THE REPORTED MOBILIT INSERT IS NOT CLEARED FOR SALE OR DISTRIBUTION IN THE USA AND THIS EVENT OCCURED OUTSIDE OF THE USA.
Additional Manufacturer Narrative
PER (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 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. AS THE SURGEON CONFIRMED THAT THE LINK BETWEEN THE DEVICES AND THE EVENT IS EXCLUDED, 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.
Description of Event or Problem
MOBILIT / TRINITY REVISION OF THE PE INSERT AND MODULAR HEAD AFTER APPROXIMATELY 1 MONTH AND 2 WEEKS DUE TO STAPHYLOCOCCUS CAPITIS. PLEASE NOTE: THE REPORTED MOBILIT INSERT IS NOT CLEARED FOR SALE OR DISTRIBUTION IN THE USA AND THIS EVENT OCCURED OUTSIDE OF THE USA.