MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; HUMERAL STEM PRIMARY, PRESS FIT 11MM

Model Number 300-01-11

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Failure of Implant (1924)

Event Date 12/07/2021

Event Type  Injury  

Event Description

As reported, approximately 5 years post op the initial rtsa, this (b)(6) female patient was revised due to the humerus and baseplate loosening.The cabled humerus from the initial surgery had failed to support the fractured humerus.The surgeon decided to use a depuy stem who had a larger head size to offer.Patient was last known to be in stable condition following the event.Devices will not be retuning due to hospital policy.

Manufacturer Narrative

Device evaluated by manufacturer: pending evaluation.Concomitant medical device(s): 320-01-38, (b)(4) - equinoxe reverse 38mm glenosphere.320-10-00, (b)(4) - equinoxe reverse tray adapter plate tray +0.320-15-01, (b)(4) - eq rev glenoid plate.320-15-05, (b)(4) - eq rev locking screw.320-20-00, (b)(4) - eq reverse torque defining screw kit.320-20-26, (b)(4) - eq rev compress screw lck cap kit, 4.5 x 26mm.320-20-30, (b)(4) - eq rev compress screw lck cap kit, 4.5 x 30mm.320-20-38, (b)(4) - eq rev compress screw lck cap kit, 4.5 x 38mm.320-20-38, (b)(4) - eq rev compress screw lck cap kit, 4.5 x 38mm.320-38-00, (b)(4) - equinoxe reverse 38mm humeral liner +0.

Manufacturer Narrative

Section h10: (h3) the revision reported was likely the result of both patient conditions and an insufficient bond between the implants and the bones, which led to aseptic (non-infected) humeral and baseplate loosening.The failed cabled humerus likely contributed to the reported humeral loosening.However, this cannot be confirmed as the devices were not returned for evaluation and x-ray images were not provided.

• Brand Name: EQUINOXE
• Type of Device: HUMERAL STEM PRIMARY, PRESS FIT 11MM
• 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: 13060147
• MDR Text Key: 282617113
• Report Number: 1038671-2021-00721
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862079312
• UDI-Public: 10885862079312
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042021
• 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: 06/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 300-01-11
• Device Catalogue Number: 300-01-11
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2016
• 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: 93 YR
• Patient Sex: Female