MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-02-21 for TRINITY NOT PROVIDED NOT APPLICABLE manufactured by Corin Medical.
[188694360]
Per (b)(4) initial report. Additional information, including device details, confirmation on which devices were explanted, post primary and pre revision x-rays, operative notes, patient details, patient medical history, an update on the patient and return of the explanted devices has been requested in order to progress with the investigation of this event, and if received, will be provided in a supplemental report upon completion of the investigation. Upon receipt of the appropriate device details the relevant device manufacturing records will be identified and 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 occurred outside of the usa.
Patient Sequence No: 1, Text Type: N, H10
[188694361]
Trinity revision due to rubbing noises.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9614209-2020-00020 |
| MDR Report Key | 9738930 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-02-21 |
| Date of Report | 2020-02-21 |
| Date of Event | 2019-11-29 |
| Date Mfgr Received | 2020-01-31 |
| Date Added to Maude | 2020-02-21 |
| 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 |
| Generic Name | ACETABULAR HIP SYSTEM WITH ECIMA LINERS |
| Product Code | MEH |
| Date Received | 2020-02-21 |
| Model Number | NOT PROVIDED |
| Catalog Number | NOT APPLICABLE |
| Lot Number | NOT PROVIDED |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2020-02-21 |