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 2020-01-21 for EQUINOXE UNK manufactured by Exactech, Inc..
[176209593]
Pending evaluation. Concomitant device(s): 320-01-38, 98506019, equinoxe reverse 38mm glenosphere, 320-15-05, 12121481, eq rev locking screw liner.
Patient Sequence No: 1, Text Type: N, H10
[176209614]
As reported, a (b)(6) male patient reported his initial right shoulder surgery was a little over a year ago. States there was no traumatic event ; however, he was using a lawnmower and heard a pop. During the revision event, the humeral adaptor tray was found disengaged from stem. The liner and glenosphere were taken out with screw as well. The patient was satisfactory upon leaving the or. The parts were returned. The patient reportedly drinks 5 beers a day. No other information available at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1038671-2020-00009 |
| MDR Report Key | 9610734 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-21 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-01-01 |
| Date Mfgr Received | 2020-03-24 |
| Date Added to Maude | 2020-01-21 |
| 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 | HUMERAL ADAPTOR TRAY, +5 |
| Product Code | KWT |
| Date Received | 2020-01-21 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2020-01-21 |