MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2015-08-07 for TRINITY ACETABULAR SYSTEM 321.04.356 NOT APPLICABLE manufactured by Corin Medical.
[22893438]
(b)(4) initial report. Device details, patient medical history, post primary and pre-revision x-ray and explant have been requested in order to progress with the investigation. Device manufacturing records will be reviewed.
Patient Sequence No: 1, Text Type: N, H10
[22893439]
Trinity revision after 2 months due to poor bone stock quality.
Patient Sequence No: 1, Text Type: D, B5
[51152011]
(b)(4). Final report. The devices were revised due to poor quality of bone stock. The device manufacturing records were reviewed and it was confirmed that the devices were manufactured to material and dimensional specification.
Patient Sequence No: 1, Text Type: N, H10
[51152012]
Trinity revision after 2 months due to poor bone stock quality.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9614209-2015-00041 |
| MDR Report Key | 4995930 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2015-08-07 |
| Date of Report | 2016-01-20 |
| Date of Event | 2015-05-13 |
| Date Mfgr Received | 2015-07-13 |
| Device Manufacturer Date | 2014-09-26 |
| Date Added to Maude | 2015-08-12 |
| 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 | MRS LUCINDA GERBER |
| Manufacturer Street | THE CORINIUM CENTRE |
| Manufacturer City | CIRENCESTER, GLOUCESTERSHIRE GL7 1YJ |
| Manufacturer Country | UK |
| Manufacturer Postal | GL7 1YJ |
| Manufacturer Phone | 1285659866 |
| Manufacturer G1 | CORIN MEDICAL |
| Manufacturer Street | THE CORINIUM CENTRE |
| Manufacturer City | CIRENCESTER, 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 ACETABULAR SYSTEM |
| Generic Name | ACETABULAR SHELL |
| Product Code | OQI |
| Date Received | 2015-08-07 |
| Model Number | 321.04.356 |
| Catalog Number | NOT APPLICABLE |
| Lot Number | 296493 |
| Device Expiration Date | 2019-09-24 |
| 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 | 2015-08-07 |