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

Catalog Number 320-01-38

Device Problem Fracture (1260)

Patient Problem Bone Fracture(s) (1870)

Event Date 04/05/2023

Event Type  Injury  

Event Description

As reported, approximately 2.5 years post op initial left tsa, this 68 y/o female patient was revised.The patient has developed an acromial stress fracture and needed her reverse shoulder replacement removed to detention the shoulder.Female patient was last known to be in stable condition following the event.No other patient.No additional information/medical history reported.Unable to obtain photos/x-rays.Product not returning - disposed.

Manufacturer Narrative

Section h10: (h3) pending evaluation.(d10) concomitant device(s): 6598770 300-01-11 - equinoxe, humeral stem primary, press fit 11mm.6551880 315-35-00 - glnd kwire.6567632 320-10-00 - equinoxe reverse tray adapter plate tray +0.6571178 320-15-01 - eq rev glenoid plate.6629013 320-15-05 - eq rev locking screw.6624035 320-20-00 - eq reverse torque defining screw kit.S084091 320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm.S084832 320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm.S059578 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm.S063506 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm.6553066 320-38-03 - equinoxe reverse 38mm humeral liner +2.5.6564430 321-20-00 - equinoxe reverse shoulder drill kit.

Manufacturer Narrative

Section h10: (h3) 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.This cause of the reported event is most likely patient conditions, however; cannot be confirmed as the device was not returned for evaluation.

• 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, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 16910066
• MDR Text Key: 314976814
• Report Number: 1038671-2023-00964
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086389
• UDI-Public: 10885862086389
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K063569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2023
• 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: 08/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2020
• 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
• Patient Sex: Female