MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional report with the FDA on 2020-02-28 for EQUINOXE 320-01-38 manufactured by Exactech, Inc..
[189080295]
Pending evaluation. Concomitant device(s): 15mm humeral stem (300-01-15, (b)(4)); 0 adapter plate (320-10-00; 320-10-00); glenoid plate (320-15-01; (b)(4)); locking screw (320-15-05; (b)(4)); torque defining screw kit (320-20-00; (b)(4)); 26mm screw (320-20-26; (b)(4)); 34mm screw (320-20-34; (b)(4)); 34mm screw (320-20-34; (b)(4)); 38mm +0 humeral liner (320-38-00; (b)(4)).
Patient Sequence No: 1, Text Type: N, H10
[189080296]
As reported, approximately 2 years postoperative of initial right tsa, this (b)(6) y/o male patient presented with a sore inflamed right shoulder. Surgeon cultured and infection was discovered. Surgeon decided to do a one stage revision on patient - removing all implants and placing a big ball hemi. Patient is expected to do well and left the or stable. Explants are not being released by hospital so will not be returned.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1038671-2020-00227 |
| MDR Report Key | 9769475 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL |
| Date Received | 2020-02-28 |
| Date of Report | 2020-02-28 |
| Date of Event | 2020-02-21 |
| Date Mfgr Received | 2020-02-21 |
| Device Manufacturer Date | 2017-02-09 |
| 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 38MM GLENOSPHERE |
| Product Code | KWT |
| Date Received | 2020-02-28 |
| 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 | 2020-02-28 |