MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-02-28 for EQUINOXE 320-42-10 manufactured by Exactech, Inc..
[189050639]
Pending evaluation: concomitant device(s): lateralized 42 glenosphere (320-02-42, (b)(4)); glenosphere locking screw (320-15-05, (b)(4)); reverse locking torque screw (320-11-00, (b)(4)); 34mm bone screw (320-20-34, (b)(4)); humeral tray (320-10-00, (b)(4)).
Patient Sequence No: 1, Text Type: N, H10
[189050640]
As reported, the patient had failure of a reverse total shoulder due to dislocation. . Revision replaced the humeral liner and glenosphere, along with the associated locking screws. Patient was stable upon leaving the or and there was not a delay to surgery. Devices not returning due to hospital policy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1038671-2020-00225 |
| MDR Report Key | 9769066 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-02-28 |
| Date of Report | 2020-02-28 |
| Date of Event | 2020-02-19 |
| Date Mfgr Received | 2020-02-19 |
| Date Added to Maude | 2020-02-28 |
| 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 | REVERSE 42MM HUMERAL CONST LINER +0 |
| Product Code | KWT |
| Date Received | 2020-02-28 |
| Model Number | 320-42-10 |
| Catalog Number | 320-42-10 |
| 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 | 2020-02-28 |