MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-22 for EQUINOXE UNK 314-13-24 manufactured by Exactech, Inc..
[176372340]
Pending evaluation concomitant device(s): post aug cemented left (cat# 314-13-24 / sn# (b)(4)). Torque defining square drive (cat# 300-20-02 / sn# (b)(4)). Replicator plate 4. 5mm offset (cat# 300-10-45 / sn# (b)(4)).
Patient Sequence No: 1, Text Type: N, H10
[176372341]
As reported, approximately 2 years post-op the initial tsa for this (b)(6) female, the initial reason for revision was thought to be cuff failure but once we opened the patient up it was apparent the glenoid was loose. There has been catastrophic posterior wear of the component which has created an osteolytic response and then loosened the implant. Patient was last known to be in stable condition following the event. The devices will not be returned per hospital policy. All available information has been received at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1038671-2020-00012 |
| MDR Report Key | 9617875 |
| Date Received | 2020-01-22 |
| Date of Report | 2020-01-22 |
| Date of Event | 2020-01-08 |
| Date Mfgr Received | 2020-01-05 |
| Device Manufacturer Date | 2018-04-18 |
| Date Added to Maude | 2020-01-22 |
| 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 L, POST AUG, LEFT |
| Product Code | KWT |
| Date Received | 2020-01-22 |
| Model Number | UNK |
| Catalog Number | 314-13-24 |
| 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 | 2020-01-22 |