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 TRINITY 321.03.354 NOT APPLICABLE manufactured by Corin Medical.
[186608516]
Per (b)(4). Additional information, including the cup lot code, part nos. And lot cods of any other revised devices, operative notes, post primary and pre revision x-rays, patient "detais" and patient medical history was requested in order to progress with the investigation of this event, however, this information has not been provided and thus an investigation cannot be conducted. The lot code of the reported cup was not provided and thus the relevant device manufacturing records could not be identified or reviewed. As this event was not due to the performance of the device, but was the result of the patient experiencing a fall, this case is now considered closed, however, should any additional information be provided then this case may be re-opened for further investigation.
Patient Sequence No: 1, Text Type: N, H10
[186608517]
Trinity revision after approximately 5 years and 5 months due to cup migration following a fall.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9614209-2020-00030 |
| MDR Report Key | 9887846 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date of Event | 2020-02-25 |
| Date Mfgr Received | 2020-02-26 |
| 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 | TRINITY |
| Generic Name | ACETABULAR HIP SYSTEM |
| Product Code | LZO |
| Date Received | 2020-03-27 |
| Model Number | 321.03.354 |
| Catalog Number | NOT APPLICABLE |
| Lot Number | NOT PROVIDED |
| 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 | 2020-03-27 |