MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-27 for METAFIX 579.2104 NOT APPLICABLE manufactured by Corin Medical.
[188694696]
Per (b)(4) initial report. It has been confirmed that patient medical history, operative notes and the explanted devices cannot be provided for this event, however, x-rays have been provided which will be reviewed. Details will be provided in a supplemental report upon completion of the investigation. 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
[188694697]
Metafix / trinity revision after approximately 1 year and 11 months due to the patient experiencing pain.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9614209-2020-00034 |
| MDR Report Key | 9888274 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date of Event | 2020-02-27 |
| Date Mfgr Received | 2020-02-28 |
| Device Manufacturer Date | 2017-12-21 |
| Date Added to Maude | 2020-03-27 |
| 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 | METAFIX |
| Generic Name | HIP STEM |
| Product Code | LZO |
| Date Received | 2020-03-27 |
| Model Number | 579.2104 |
| Catalog Number | NOT APPLICABLE |
| Lot Number | 373664 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| 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 | 2020-03-27 |