MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-27 for EQUINOXE UNK manufactured by Exactech, Inc..
[189067727]
Pending evaluation. Concomitant device(s): humeral tray, torque screw, humeral liner, glenosphere, glenosphere locking screw, compression screw/locking cap.
Patient Sequence No: 1, Text Type: N, H10
[189067728]
As reported, approximately 3. 5 years post implantation of a reverse prosthesis, a revision was completed on this (b)(6)y/0 female due to aseptic glenoid loosening. Gradual lucencies around right humeral component noted. The study indicated the event is possibly related to the device and definitely related to the procedure. Patient was revised to reverse with humeral reconstruction stem. Patient was an inpatient x 3days. Patient has history of smoking and liver disease. No other information is available
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1038671-2020-00264 |
| MDR Report Key | 9890532 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date of Event | 2020-03-06 |
| Date Mfgr Received | 2020-03-18 |
| 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 | KATE JACOBSON |
| Manufacturer Phone | 3523771140 |
| Manufacturer G1 | EXACTECH, INC. |
| Manufacturer Street | 2320 NW 66 CT |
| Manufacturer City | GAINESVILLE FL 32653 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32653 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EQUINOXE |
| Generic Name | FRACTURE HUMERAL STEM |
| Product Code | KWT |
| Date Received | 2020-03-27 |
| Catalog Number | UNK |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EXACTECH, INC. |
| Manufacturer Address | 2320 NW 66 COURT GAINESVILLE FL 32653 US 32653 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2020-03-27 |