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

Model Number 320-01-38

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Failure of Implant (1924)

Event Date 05/25/2023

Event Type  Injury  

Event Description

As reported, the patient had an initial left tsa on (b)(6) 2018.The patient was revised on (b)(6) 2023 due to repeat dislocations.New reverse components were implanted.There was no reported breakage of a device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.No other patient information/medical history reported.

Manufacturer Narrative

Pending investigation.D10: 5143706 300-01-13 - equinoxe, humeral stem primary, press fit 13mm.5048172 315-35-00 - glnd kwire.5048206 315-35-00 - glnd kwire.5201214 315-35-00 - glnd kwire.3909106 320-10-05 - equinoxe reverse tray adapter plate tray +5.4838417 320-15-03 - rs glenoid plate post aug, 8 deg, left.5158524 320-15-05 - eq rev locking screw.5140945 320-20-00 - eq reverse torque defining screw kit.5103634 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm.5190833 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm.5011600 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm.5171651 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm.3874478 320-38-10 - equinoxe reverse 38mm humeral const liner +0.5175206 321-20-00 - equinoxe reverse shoulder drill kit.

Manufacturer Narrative

H3: upon review of the available information, there is no evidence that this is a device related malfunction and there is no allegation against the device.Implantation of a total joint could result scapular notching and dislocation.The most likely cause of the reported event is patient conditions.

• 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 66th ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 17322286
• MDR Text Key: 319100717
• Report Number: 1038671-2023-01659
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 320-01-38
• Device Catalogue Number: 320-01-38
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2017
• 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 Outcome(s): Required Intervention
• Patient Sex: Male