MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-27 for EQUINOXE 310-01-44 manufactured by Exactech, Inc..
[189066726]
Pending evaluation: concomitant device(s): screw kit 300-20-01, sn (b)(4); humeral stem 300-01-13, sn (b)(4); replicator plate 300-10-45, sn (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[189066727]
Approximately 16 months post initial tsa, the (b)(6) years old female patient presented to the surgeon with, what appeared as, an infected, loosening primary right tsa. On xray, the stem appears lose with "windshield wiper" effect. Head appears in place on xray. The patient was scoped to take biopsies for infection, which were negative. Upon scoping, it was apparent that replicator plate had dissociated from top of the stem. There was also obvious metallosis. Shoulder joint was debrided with shaver and biopsies were taken. Shoulder has not yet been revised. Patient was last known to be in stable condition following the event. The surgery on the right shoulder was completed on (b)(6) 2020. Upon opening the shoulder, the head had not dissociated from the stem. It turns out the stem was loose due to an infection. The devices will not return, the patient asked for the devices. Patient is ok except for the infection found in the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1038671-2020-00262 |
| MDR Report Key | 9890528 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date of Event | 2020-03-02 |
| Date Mfgr Received | 2020-03-02 |
| Device Manufacturer Date | 2017-10-13 |
| Date Added to Maude | 2020-03-27 |
| 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 KATE.JACOBSON@EXAC.COM |
| 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 | HUMERAL HEAD SHORT, 44MM (ALPHA) |
| Product Code | KWT |
| Date Received | 2020-03-27 |
| Model Number | 310-01-44 |
| Catalog Number | 310-01-44 |
| 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 | 2020-03-27 |