MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-01-21 for EQUINOXE UNK 320-01-38 manufactured by Exactech, Inc..
[176269061]
As reported, the initial implant was (b)(6) 2019. The surgeon decided to revise this female patient? S shoulder due to reoccurring dislocations on (b)(6) 2020. The stem, adapter tray and liner were removed quite easily and removed the glenosphere. He then implanted a 38+4 glenosphere with screw and implanted a size 10 preserve stem, a +0-adapter tray and + 0 constrained liner. The shoulder was reduced and closed the wound. The patient left the or in stable condition. All available information has been received. In a review of the labeling and ifu (b)(4) rev. N, the patient should be cautioned to monitor activities and protect the replaced joint from unreasonable stresses, and follow the written instructions of the physician with respect to follow-up care and treatment. Upon review of the available information, there is no evidence that this is a device related problem and there is no allegation against the device. Implantation of a total joint could result pain, infection, dislocation, or loosening of total joint hardware. The most likely cause of the reported event is the patient conditions. Concomitant device(s): equinoxe preserve stem 8mm (cat# 300-30-08 / sn# (b)(4)) , equinoxe reverse tray adapter plate tray +0 (cat# 320-10-00), eq rev locking screw (cat# 320-15-05 / sn# (b)(4)), eq reverse torque defining screw kit (cat# 320-20-00 / sn# (b)(4)) , equinoxe reverse 38mm humeral liner +0 (cat# 320-38-00 / sn# (b)(4)).
Patient Sequence No: 1, Text Type: N, H10
[176269062]
As reported, the initial implant was (b)(6) 2019. The surgeon decided to revise this female patient? S shoulder due to reoccurring dislocations on (b)(6) 2020. The stem, adapter tray and liner were removed quite easily and removed the glenosphere. He then implanted a 38+4 glenosphere with screw and implanted a size 10 preserve stem, a +0-adapter tray and + 0 constrained liner. The shoulder was reduced and closed the wound. The patient left the or in stable condition. All available information has been received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1038671-2020-00010 |
| MDR Report Key | 9610996 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-01-21 |
| Date of Report | 2020-01-21 |
| Date of Event | 2020-01-07 |
| Date Mfgr Received | 2020-01-06 |
| Device Manufacturer Date | 2019-03-26 |
| Date Added to Maude | 2020-01-21 |
| 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 38MM GLENOSPHERE |
| Product Code | KWT |
| Date Received | 2020-01-21 |
| Model Number | UNK |
| Catalog Number | 320-01-38 |
| 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 | 2020-01-21 |