MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-02-26 for EQUINOXE 320-01-42 manufactured by Exactech, Inc..
[189048948]
Pending evaluation. Concomitant device(s): equinoxe reverse tray adapter plate tray +0 (cat#: 320-10-00, sn#: (b)(4)); eq rev locking screw (cat#: 320-15-05, sn#: (b)(4)); eq reverse torque defining screw kit (cat#: 320-20-00, sn#: (b)(4)); equinoxe reverse 42mm humeral liner +2. 5 (cat#: 320-2-03, sn#: (b)(4)).
Patient Sequence No: 1, Text Type: N, H10
[189048949]
As reported, approximately 23 months postoperatively a left tsa, a (b)(6) y/o male patient was dislocating and underwent a revision. The surgeon dissected down to the joint, removed the liner and adapter tray from the stem and removed the locking screw and glenosphere. Then a 42mm +4mm offset glenosphere with locking screw was implanted. He then trialed a +10 adapter tray with a 42mm +0 liner and determined he liked those sizes and proceeded to implant the real implants. The patient was relocated and closed in the usual fashion. Patient left the or stable and is expected to have a good outcome. Devices are not returning due to hospital policy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1038671-2020-00218 |
| MDR Report Key | 9757248 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-02-26 |
| Date of Report | 2020-02-26 |
| Date of Event | 2020-02-12 |
| Date Mfgr Received | 2020-02-12 |
| Device Manufacturer Date | 2018-02-09 |
| Date Added to Maude | 2020-02-26 |
| 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 GLENOSPHERE |
| Product Code | KWT |
| Date Received | 2020-02-26 |
| Model Number | 320-01-42 |
| Catalog Number | 320-01-42 |
| 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 | 2020-02-26 |