MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-07-09 for EQUINOXE manufactured by Exactech, Inc..
[3685773]
Revision due to premature loosening of the glenoid component approximately one year post operatively.
Patient Sequence No: 1, Text Type: D, B5
[11038913]
Mfr is currently following up regarding the availability of the device for evaluation. This event was also reported by the user on medwatch uf/importer report (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1038671-2013-00066 |
| MDR Report Key | 3229821 |
| Report Source | 07 |
| Date Received | 2013-07-09 |
| Date of Report | 2013-07-09 |
| Date of Event | 2013-05-31 |
| Date Mfgr Received | 2013-06-18 |
| Date Added to Maude | 2013-07-22 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MELISSA CHRISTENSEN |
| Manufacturer Street | 2320 N.W. 66TH CT. |
| Manufacturer City | GAINESVILLE FL 32653 |
| Manufacturer Country | US |
| Manufacturer Postal | 32653 |
| Manufacturer Phone | 8003922832 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EQUINOXE |
| Generic Name | GLENOID COMPONENT |
| Product Code | KYM |
| Date Received | 2013-07-09 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EXACTECH, INC. |
| Manufacturer Address | 2320 N.W. 66TH CT. GAINESVILLE FL 32653 US 32653 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2013-07-09 |