MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-12-17 for TRINITY 322.02.632 NOT APPLICABLE manufactured by Corin Medical.
[173190351]
Per -2623 initial report. Additional information, including x-rays, operative notes, patient details, an update on the patient, pre-operative planning documents and the return of the explanted devices was requested in order to progress with the investigation of this event, however, not all information could be provided and thus the investigation of this event is limited. Pre-operative planning documents have been provided and will be reviewed at corin. It has been confirmed that the explants cannot be returned for examination. The appropriate device details have been provided and 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
[173190352]
Trinity revision of the ecima liner and cocr modular head after approximately 10 months due to dislocation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9614209-2019-00133 |
| MDR Report Key | 9481441 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-12-17 |
| Date of Report | 2020-03-19 |
| Date of Event | 2019-12-02 |
| Date Mfgr Received | 2019-11-27 |
| Device Manufacturer Date | 2018-05-04 |
| Date Added to Maude | 2019-12-17 |
| 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 |
| Generic Name | ACETABULAR HIP SYSTEM WITH ECIMA LINERS |
| Product Code | MEH |
| Date Received | 2019-12-17 |
| Model Number | 322.02.632 |
| Catalog Number | NOT APPLICABLE |
| Lot Number | 384293 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2019-12-17 |