MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE 38MM GLENOSPHERE; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number 320-01-38

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Failure of Implant (1924)

Event Date 12/14/2021

Event Type  Injury  

Event Description

Study: equinoxe shoulder study subject: (b)(6).Date of event onset : 12-14-2021 adverse event name : disassociation of glenosphere briefly describe adverse event : the patient following a right hemilated hemorrhagic stroke in 2019 reports pain and functional impotence serious adverse event? : yes ae related to device? : definitely not related ae related to procedure? : definitely not related no action taken.Outcome is unknown stating the patient refuses preothesis revision surgery.320-01-38 - equinoxe reverse 38mm glenosphere 510k: k063569 concomitants: 300-01-15 - equinoxe, humeral stem primary, press fit 15mm 320-38-00 - equinoxe reverse 38mm humeral liner +0 320-10-00 - equinoxe reverse tray adapter plate tray +0 320-15-04 - rs glenoid plate r post aug, 8 deg, right 73 yo white male height: 165 cm weight: 70 kgs bmi: 26 diagnosis: rotator cuff arthropathy comorbidities: hypertension.

Manufacturer Narrative

(h3) pending evaluation (d10) concomitant device(s): 300-01-15 - equinoxe, humeral stem primary, press fit 15mm 320-38-00 - equinoxe reverse 38mm humeral liner +0 320-10-00 - equinoxe reverse tray adapter plate tray +0 320-15-04 - rs glenoid plate r post aug, 8 deg, right.

• Brand Name: EQUINOXE REVERSE 38MM GLENOSPHERE
• Type of Device: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH; 2320 nw 66th ct.; gainesville FL 32653
• Manufacturer Contact: miguel sosa ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18518988
• MDR Text Key: 332936960
• Report Number: 1038671-2024-00093
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086389
• UDI-Public: 10885862086389
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K06356
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 320-01-38
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 70 KG
• Patient Race: White