MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2016-08-10 for AEQUALIS REVERSED CUSTOM manufactured by Tornier Inc..
[51753753]
This is the final report submitted regarding this surgical event and medical device. Literature source: early outcomes following metal-on-metal reverse total shoulder arthroplasty in patients younger than 50 years. Clay riley, md; john idoine, do; yousef shishani, md; reuben gobezie, md; bradley edward s, md. Orthopedics. 2016 jun 23:1-5. Http://www. Ncbi. Nlm. Nih. Gov/pubmed/27337662.
Patient Sequence No: 1, Text Type: N, H10
[51753754]
It was reported in the literature: "glenoid fracture with baseplate loosening; baseplate removal and glenoid bone grafting, then later revised" no further patient complications or surgical details have been reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004983210-2016-00030 |
| MDR Report Key | 5865485 |
| Report Source | LITERATURE |
| Date Received | 2016-08-10 |
| Date of Report | 2016-07-19 |
| Date Mfgr Received | 2016-07-19 |
| Date Added to Maude | 2016-08-10 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. DUSTIN SMITH |
| Manufacturer Street | 10801 NESBIT AVE SOUTH |
| Manufacturer City | BLOOMINGTON MN 55437 |
| Manufacturer Country | US |
| Manufacturer Postal | 55437 |
| Manufacturer Phone | 9529217121 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AEQUALIS REVERSED CUSTOM |
| Generic Name | SHOULDER JOINT METAL/METAL CUSTOM PROSTHESIS |
| Product Code | KWR |
| Date Received | 2016-08-10 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TORNIER INC. |
| Manufacturer Address | 10801 NESBIT AVENUE SOUTH BLOOMINGTON MN 55437 US 55437 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-08-10 |