MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-02-10 for EQUINOXE UNK 320-20-00 manufactured by Exactech, Inc..
[186832178]
Pending evaluation. Concomitant device(s): humeral adapter tray (cat#: 320-10-00 / sn#: (b)(4). 42mm humeral liner (cat#: 320-42-00 / sn#: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[186832179]
As reported, the initial implant of the (b)(6) male patient's left shoulder was (b)(6) 2019. The patient complained of "clicking" sound in his left shoulder to surgeon some time after surgery. After x-raying the shoulder the surgeon discovered that the humeral platform tray had separated from the humeral stem with humeral liner still attached to the tray. The patient was then scheduled for a left shoulder revision on (b)(6) 2020. The surgeon revised the patient's shoulder by replacing the humeral tray, torque screw, and humeral liner. Upon initial inspection of failed implants there did not appear to be any obvious signs of failure. Possible worn down/stripped threads on the end of the torque screw. Replaced torque screw and humeral tray had no issues implanting and fixating into the humeral stem. Patient was last known to be in stable condition following the event. Product will be returned for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1038671-2020-00036 |
| MDR Report Key | 9687443 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-02-10 |
| Date of Report | 2020-02-10 |
| Date of Event | 2020-02-03 |
| Date Mfgr Received | 2020-02-03 |
| Device Manufacturer Date | 2019-08-05 |
| Date Added to Maude | 2020-02-10 |
| 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 | REVERSE TORQUE DEFINING SCREW KIT |
| Product Code | KWT |
| Date Received | 2020-02-10 |
| Model Number | UNK |
| Catalog Number | 320-20-00 |
| 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 | 2020-02-10 |