MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-20 for EQUINOXE 320-01-38 manufactured by Exactech, Inc..
[189056337]
Pending evaluation. Concomitant device(s): equinoxe reverse tray adapter plate tray +10 (cat# 320-10-10, sn# (b)(4)), stem, liner, screws.
Patient Sequence No: 1, Text Type: N, H10
[189056338]
As reported, approximately 11 years postop this male patient? S initial tsa, the patient was revised to a reverse tsa following 6 months of conservative treatment for a fracture. Eight months later, an infection was evident on imaging but not picked up till (b)(6). During a revision to reverse tsa on (b)(6) 2020, all implants were removed, and a second stage revision will be planned. Patient was last known to be in stable condition following the event. Devices not returned due to hospital policy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1038671-2020-00250 |
| MDR Report Key | 9860503 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-20 |
| Date of Event | 2020-02-03 |
| Date Mfgr Received | 2020-02-03 |
| Date Added to Maude | 2020-03-20 |
| 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 38MM GLENOSPHERE |
| Product Code | KWT |
| Date Received | 2020-03-20 |
| Model Number | 320-01-38 |
| Catalog Number | 320-01-38 |
| 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 | 2020-03-20 |