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 EQUINOXE REVERSE 46MM GLENOSPHERE 320-01-46 manufactured by Exactech, Inc..
[189051139]
Pending evaluation. Concomitant device(s): 320-10-05; (b)(4); +5 adapter plate tray; 320-15-05; (b)(4); reverse locking screw; 320-20-00; (b)(4); torque defining screw kit; 320-46-13; (b)(4); reverse 46mm constrained humeral liner +2. 5; 300-01-17; (b)(4); 17mm humeral stem; 320-15-02; (b)(4); 10 degree augmented glenoid plate; 320-20-22; (b)(4); 22mm screw; 320-20-34; (b)(4); 34mm screw; 320-20-38; (b)(4); 38mm screw; 320-20-38; (b)(4); 38mm screw.
Patient Sequence No: 1, Text Type: N, H10
[189051140]
This event is the (b)(6) y/o male patient's 3rd revision surgery on right shoulder. Approximately 26 months postoperative his last revision, the patient presented with painful shoulder and warm red skin. Surgeon cultured and evidence of elevated white count was found. X-rays revealed osteolysis of proximal lateral humerus. Surgeon chose to remove old reverse implants and do a single stage hemi arthroplasty to treat patient. Surgery went well and surgeon expects a good outcome for the patient. Patient was last known to be in stable condition following the event. Device are to be returned.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1038671-2020-00228 |
| MDR Report Key | 9770502 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-02-28 |
| Date of Report | 2020-02-28 |
| Date of Event | 2020-02-17 |
| Date Mfgr Received | 2020-02-17 |
| Device Manufacturer Date | 2018-12-18 |
| 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 46MM GLENOSPHERE |
| Product Code | KWT |
| Date Received | 2020-02-28 |
| Model Number | EQUINOXE REVERSE 46MM GLENOSPHERE |
| Catalog Number | 320-01-46 |
| 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 |