MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-01-16 for EQUINOXE UNK 320-31-36 manufactured by Exactech, Inc..
[175236619]
Pending evaluation concomitant device(s): humeral stem or stemless (cat# 300-30-06), reverse humeral liner (cat# 320-36-00), reverse humeral tray (cat# 320-10-00), reverse glenosphere baseplate (cat# 320-35-03).
Patient Sequence No: 1, Text Type: N, H10
[175236620]
As reported, the (b)(6) female patient has a history of rotator cuff repair, primary glenohumeral arthrosis, hypertension, and hyperthyroidism. This patient? S initial left tsa of the was on (b)(6) 2019. The patient was revised on (b)(6) 2019 due to septic loosening. The devices will not be returned. The study database indicates the event is resolved. All available information has been received at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1038671-2020-00005 |
| MDR Report Key | 9595892 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-01-16 |
| Date of Report | 2020-01-16 |
| Date of Event | 2019-12-20 |
| Date Mfgr Received | 2019-12-31 |
| Date Added to Maude | 2020-01-16 |
| 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 | GLENOSPHERE, 36MM |
| Product Code | KWT |
| Date Received | 2020-01-16 |
| Model Number | UNK |
| Catalog Number | 320-31-36 |
| 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 | 2020-01-16 |