MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-04 for EQUINOXE UNK manufactured by Exactech, Inc..
[181961024]
Pending evaluation. Concomitant medical device(s): replicator plate. Torque screw. Humeral head.
Patient Sequence No: 1, Text Type: N, H10
[181961025]
As reported by the (b)(6) study, approximately 52 months postoperative the initial implant, this (b)(6) y/o male patient, weight (b)(6) lbs experienced a disassociation of polyethylene of the left shoulder, shear failure without mechanisms. The event is related to the device and possibly related to the procedure. Device will not be returned due to this is a study patient. No other information available at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1038671-2020-00239 |
| MDR Report Key | 9786231 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-04 |
| Date of Report | 2020-03-04 |
| Date of Event | 2020-02-26 |
| Date Mfgr Received | 2020-03-02 |
| Date Added to Maude | 2020-03-04 |
| 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 | GLENOID |
| Product Code | KWT |
| Date Received | 2020-03-04 |
| Catalog 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 | 2020-03-04 |