MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-17 for EQUINOXE 320-20-00 manufactured by Exactech, Inc..
[189055221]
Pending evaluation. Concomitant device(s): 320-42-03, (b)(4)- equinoxe reverse 42mm humeral liner +2. 5; 320-15-05, (b)(4)- eq rev locking screw; 320-10-05, (b)(4)- equinoxe reverse tray adapter plate tray +5; 300-01-19, (b)(4)- equinoxe humeral stem primary press fit 19mm; 320-01-42, (b)(4)- equinoxe reverse 42mm glenosphere.
Patient Sequence No: 1, Text Type: N, H10
[189055222]
This revision for the (b)(6) y/o male was the second revision of the patient's equinoxe reverse shoulder. The patient came back to the office after the first revision with the same issue a couple of months later. The surgical plan was to replace the reverse torque defining screw and see if the original shoulder stem was stripped. The shoulder stem was removed and we replaced with a new larger stem-size19, a new proximal humeral tray, fixed angle torque defying screw, glenosphere, glenosphere screw, and reverse liner. Upon review it seemed that the original size 17 humeral stem was stripped. At post-op follow up with the surgeon, the patient is doing fine following surgery. This was the patient second revision due to the compromised threads in the stem that caused the torque defining screw to back out.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1038671-2020-00245 |
| MDR Report Key | 9841526 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-24 |
| Date of Event | 2020-02-26 |
| Date Mfgr Received | 2020-03-18 |
| Device Manufacturer Date | 2019-10-25 |
| Date Added to Maude | 2020-03-17 |
| 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 TORQUE DEFINING SCREW KIT |
| Product Code | KWT |
| Date Received | 2020-03-17 |
| Returned To Mfg | 2020-02-26 |
| Model Number | 320-20-00 |
| Catalog Number | 320-20-00 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2020-03-17 |