MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-08-04 for TRINITY E321.032 NOT APPLICABLE manufactured by Corin Medical.
[51147756]
(b)(4) initial report. Additional information, including patient medical history, post primary and pre revision x-rays and the explants have been requested in order to progress with this investigation, and if received, will be provided in a supplemental report upon completion of the investigation. The appropriate device details were provided and the relevant device manufacturing records have been retrieved and reviewed, it was found that the parts associated with these records conformed to material and dimensional specification when manufactured.
Patient Sequence No: 1, Text Type: N, H10
[51147757]
Trinity revision due to dislocation. The surgeon replaced the trinity modular head and implanted a new walled trinity liner in a different orientation.
Patient Sequence No: 1, Text Type: D, B5
[51466101]
(b)(4). Please note: this mdr was originally filed on 06 may 2016 to an esubmissions test account. Additional information, including the explants and post primary and pre-revision x-rays were requested, however, these were not provided, therefore, there was limited information available for the investigation. Device manufacturing records were reviewed and it was confirmed that the parts were manufactured to the correct specification at the time of manufacture.
Patient Sequence No: 1, Text Type: N, H10
[51466102]
Trinity revision due to dislocation. The surgeon replaced the trinity modular head and implanted a new walled trinity liner in a different orientation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9614209-2016-00001 |
| MDR Report Key | 5846445 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-08-04 |
| Date of Report | 2016-08-09 |
| Date of Event | 2015-11-24 |
| Date Mfgr Received | 2015-12-09 |
| Device Manufacturer Date | 2011-02-23 |
| Date Added to Maude | 2016-08-04 |
| 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 |
| Generic Name | ACETABULAR HIP SYSTEM WITH ECIMA LINERS |
| Product Code | OQI |
| Date Received | 2016-08-04 |
| Model Number | E321.032 |
| Catalog Number | NOT APPLICABLE |
| Lot Number | 191910 |
| Device Expiration Date | 2016-02-29 |
| 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 | 2016-08-04 |