MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-11-28 for TRINITY DUAL MOBILITY 325.03.040 NOT APPLICABLE manufactured by Corin Medical.
| Report Number | 9614209-2019-00122 |
| MDR Report Key | 9389612 |
| Date Received | 2019-11-28 |
| Date of Report | 2019-11-28 |
| Date of Event | 2019-11-02 |
| Date Mfgr Received | 2019-11-06 |
| Device Manufacturer Date | 2019-06-28 |
| Date Added to Maude | 2019-11-28 |
| 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 | 0 |
| Brand Name | TRINITY DUAL MOBILITY |
| Generic Name | ACETABULAR HIP SYSTEM WITH ECIMA LINERS |
| Product Code | MEH |
| Date Received | 2019-11-28 |
| Model Number | 325.03.040 |
| Catalog Number | NOT APPLICABLE |
| Lot Number | 430839 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| 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 | 2019-11-28 |