MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-17 for TRINITY DUAL MOBILITY 321.02.348 NOT APPLICABLE manufactured by Corin Medical.
[187240410]
Per (b)(4). The appropriate device details were provided and the relevant device manufacturing records have been identified and reviewed. It was found that all finished parts associated with these records were manufactured, packed and sterilised to the correct specifications at the time of manufacture. The sterilisation method and sterile barrier system used to package trinity dual mobility devices has a long history of safe and effective use at corin for a wide range of orthopaedic devices and has been validated in accordance with the relevant standards. Infection is a known complication with any invasive surgery and thus 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.
Patient Sequence No: 1, Text Type: N, H10
[187240411]
Trinity dual mobility revision after approximately 2 months due to infection.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9614209-2020-00029 |
| MDR Report Key | 9841938 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-17 |
| Date of Event | 2020-02-25 |
| Date Mfgr Received | 2020-03-02 |
| Device Manufacturer Date | 2019-01-15 |
| Date Added to Maude | 2020-03-17 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR FRANCK DIDIER |
| Manufacturer Street | THE CORINIUM CENTRE CIRENCESTER |
| Manufacturer City | GLOUCESTERSHIRE, GL7 1YJ |
| Manufacturer Country | UK |
| Manufacturer Postal | GL7 1YJ |
| Manufacturer G1 | CORIN MEDICAL |
| Manufacturer Street | THE CORINIUM CENTRE CIRENCESTER |
| Manufacturer City | GLOUCESTERSHIRE, GL7 1YJ |
| Manufacturer Country | UK |
| Manufacturer Postal Code | GL7 1YJ |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRINITY DUAL MOBILITY |
| Generic Name | ACETABULAR HIP SYSTEM |
| Product Code | MEH |
| Date Received | 2020-03-17 |
| Model Number | 321.02.348 |
| Catalog Number | NOT APPLICABLE |
| Lot Number | 407184 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CORIN MEDICAL |
| Manufacturer Address | THE CORINIUM CENTRE CIRENCESTER GLOUCESTERSHIRE, GL7 1YJ UK GL7 1YJ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2020-03-17 |