MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; REVERSE 42MM HUMERAL LINER +2.5

Model Number 320-42-03

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Failure of Implant (1924)

Event Date 10/11/2021

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.Concomitant device(s): 320-02-42, 5380684 - rs expanded glenosphere 42mm +4.320-10-00, 5503309 - eq rs tray adapter plate tray +0.320-15-05, 5420882 - eq rs locking screw.320-20-00, 5434612 - eq rs torque screw.

Event Description

Approximately 3 yrs and 2 months postop the initial rtsa, the (b)(6) male patient¿s humeral liner became disassociated at an unknown time prior to revision.When the patient finally came to be seen by staff to be treated, the components had been metal on metal to the point that the glenosphere had worn through the humeral tray and torque screw.The humeral tray and torque screw were removed with broken screw removal tools and the humeral stem was able to be reused.A new tray, liner, torque screw, glenosphere and glenosphere locking screw were implanted and pt.Was deemed stable.Patient was last known to be in stable condition following the event the device will not return for evaluation due to facility policy.

Manufacturer Narrative

Section h10: (h3) the revision reported may have been the result of either incomplete seating of the liner during implantation, bone impingement, patient-related conditions, or any combination of these possibilities, which led to humeral liner disassociation.The broken humeral tray was likely the result of the glenosphere articulating on the humeral tray over time after the humeral liner disassociation occurred, which led to crack initiation, propagation, and ultimate fracture of the humeral tray.However, this cannot be confirmed as the devices were not available for evaluation and radiographs were not provided.

• Brand Name: EQUINOXE
• Type of Device: REVERSE 42MM HUMERAL LINER +2.5
• 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: 12726854
• MDR Text Key: 279261061
• Report Number: 1038671-2021-00559
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086709
• UDI-Public: 10885862086709
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 04/29/2022

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 Expiration Date: 05/09/2023
• Device Model Number: 320-42-03
• Device Catalogue Number: 320-42-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/12/2021
• Initial Date FDA Received: 11/01/2021
• Supplement Dates Manufacturer Received: 04/12/2022
• Supplement Dates FDA Received: 04/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2018
• 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): Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male