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 320-10-00 manufactured by Exactech, Inc..
[181340725]
Pending evaluation. Concomitant medical device(s): 38mm glenosphere (320-01-38; (b)(4)). Locking screw (320-15-05; (b)(4)). Torque defining screw (320-20-00; (b)(4)). 38mm humeral liner (320-38-00; (b)(4)).
Patient Sequence No: 1, Text Type: N, H10
[181340726]
As reported, approximately 16 months postoperative a left reverse total shoulder arthroplasty this male patient was revised due to instability. The shoulder was opened in standard fashion and the adapter tray, humeral liner, glenosphere and locking screw were removed in the usual way. Better stability was achieved by lateralizing the glenosphere (42mm +4offset) and upsizing the poly (42mm +2. 5). The procedure was completed, and the patient left the operating room in stable condition. Devices not returned due to hospital policy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1038671-2020-00222 |
| MDR Report Key | 9768858 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-02-28 |
| Date of Report | 2020-03-04 |
| Date of Event | 2020-02-13 |
| Date Mfgr Received | 2020-02-13 |
| Device Manufacturer Date | 2018-10-05 |
| 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 TRAY ADAPTER PLATE TRAY +0 |
| Product Code | KWT |
| Date Received | 2020-02-28 |
| Model Number | 320-10-00 |
| Catalog Number | 320-10-00 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2020-02-28 |