MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE 42MM HUMERAL LINER +2.5; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number 320-42-03

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Failure of Implant (1924)

Event Date 10/06/2023

Event Type  Injury  

Manufacturer Narrative

Pending evaluation concomitant device(s): 6725140 320-01-42 equinoxe reverse 42mm glenosphere.A135420 320-10-00 - equinoxe reverse tray adapter plate tray +0.A146061 320-15-05 - eq rev locking screw.

Event Description

As reported, approximately 11 months post op initial left tsa, this 71 y/o male patient was revised.Patient dislocated his shoulder in aug ¿ failed to reduce intro-operatively at public hospital.Humeral liner was disassociated from the humeral tray.Patient was revised to a +4mm glenosphere, +5mm humeral tray, and a constrained humeral liner.Patient was last known to be in stable condition following the event.No other patient information/medical history reported.Product not returning - disposed at hospital.

Manufacturer Narrative

H3: the revision reported may have been the result of patient conditions, an unreported traumatic event, or disassociation of the humeral liner.However, this cannot be confirmed as the devices were not returned for evaluation and images/radiographs were not provided.Additionally, disassociation of the humeral liner prior to the shoulder dislocation and subsequent failed attempts to reduce the shoulder cannot be confirmed from the information provided.

• Brand Name: EQUINOXE REVERSE 42MM HUMERAL LINER +2.5
• 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 ; 2320 nw 66 ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18016471
• MDR Text Key: 326675602
• Report Number: 1038671-2023-02616
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086709
• UDI-Public: 10885862086709
• Combination Product (y/n): N
• Reporter Country Code: NZ
• 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: 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: 320-42-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2020
• 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
• Treatment: SEE H10
• Patient Age: 71 YR
• Patient Sex: Male