MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2015-08-17 for TRINITY ACETABULAR SYSTEM 321.05.366 NOT APPLICABLE manufactured by Corin Medical.
[23523268]
(b)(4). Pt medical history, event details, pt outcome and the 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
[23523269]
Trinity shell, ecima liner and ceramic modular head revision, after 7 months, due to a fractured pelvis.
Patient Sequence No: 1, Text Type: D, B5
[51493020]
(b)(4). Final report. The patient fell, resulting in fracture of acetabulum and subsequent movement of the trinity implants. As the patient did not seek immediate medical attention, and thus continued to ambulate on the now misaligned implants, damage occurred to the implants. Following a review of the manufacturing records it was confirmed that the corin implants were manufactured to the correct dimensional and material specification. The corin implants did not contribute to the requirement for revision. 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
[51493021]
Trinity shell, ecima liner and ceramic modular head revision after 7 months due to a fractured pelvis following a fall.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9614209-2015-00043 |
| MDR Report Key | 5015773 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2015-08-17 |
| Date of Report | 2016-08-08 |
| Date of Event | 2015-07-28 |
| Date Mfgr Received | 2015-07-31 |
| Device Manufacturer Date | 2011-11-30 |
| Date Added to Maude | 2015-08-19 |
| 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 | 2015-08-17 |
| Returned To Mfg | 2016-01-07 |
| Model Number | 321.05.366 |
| Catalog Number | NOT APPLICABLE |
| Lot Number | 211436 |
| Device Expiration Date | 2016-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2015-08-17 |