MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; REVERSE 38MM HUMERAL LINER +0

Model Number 320-38-00

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 10/26/2021

Event Type  Injury  

Event Description

As reported, the female patient dislocated right shoulder on 1st post-op day, patient was revised the following day with a liner change.Patient was last known to be in stable condition following the event the device was disposed by the facility.

Manufacturer Narrative

Pending evaluation.Concomitant device(s): 320-15-04, 6965886 - rs glenoid plate post aug, 8 deg, right, 320-15-05, 7064167 - eq rev locking screw 320-01-38, 6745107 - equinoxe reverse 38mm glenosphere, 320-20-00, 7005342 - eq reverse torque defining screw kit, 320-10-00, 7022841 - equinoxe reverse tray adapter plate tray +0, 300-01-11, 7000134 - equinoxe, humeral stem primary, press fit 11mm.

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
• Type of Device: REVERSE 38MM HUMERAL LINER +0
• 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: 12821224
• MDR Text Key: 285472914
• Report Number: 1038671-2021-00620
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086655
• UDI-Public: 10885862086655
• 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: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 320-38-00
• Device Catalogue Number: 320-38-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/27/2021
• Initial Date FDA Received: 11/16/2021
• Supplement Dates Manufacturer Received: 04/21/2022
• Supplement Dates FDA Received: 05/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2021
• 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 Outcome(s): Required Intervention; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Female