MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-23 for EQUINOXE 314-13-14 manufactured by Exactech, Inc..
[189056644]
Pending evaluation. Concomitant device(s): humeral head extra short, offset 50mm x 16fmm (cat# 310-00-50 / sn# (b)(4)); torque defining square drive screw kit (cat# 300-20-02 / sn# (b)(4)); replicator plate 1. 5mm offset short (cat# 300-50-15 / sn# (b)(4)); humeral stem primary, press-fit 17mm (cat# 300-01-17 / sn# (b)(4)).
Patient Sequence No: 1, Text Type: N, H10
[189056645]
As reported. Approximately 2 years postop initial implant, with intentions of changing a patient's anatomic right shoulder to a reverse shoulder, a surgeon explanted this manufacturer? S anatomic shoulder and implanted a competitor? S antibiotic spacer from this (b)(6) y/o male, who weighs (b)(6) lbs. The caged glenoid appeared to be loose during the case and probably infected. The patient was last known to be in stable condition following the event. Devices not returning per hospital policy. All available information has been received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1038671-2020-00253 |
| MDR Report Key | 9864696 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-23 |
| Date of Event | 2020-03-12 |
| Date Mfgr Received | 2020-03-12 |
| Device Manufacturer Date | 2015-01-07 |
| Date Added to Maude | 2020-03-23 |
| 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 | CAGE GLENOID LARGE, BETA |
| Product Code | KWT |
| Date Received | 2020-03-23 |
| Model Number | 314-13-14 |
| Catalog Number | 314-13-14 |
| Lot Number | UNK |
| Device Expiration Date | 2020-01-06 |
| 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 | 2020-03-23 |