MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; HUMERAL STEM PRIMARY PRESS FIT 12MM

Model Number 300-01-12

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

Patient Problem Failure of Implant (1924)

Event Date 09/21/2021

Event Type  Injury  

Manufacturer Narrative

Device evaluated by mfr: pending evaluation.Concomitant device(s): 310-00-44, 120827002 - xs humeral head, 44mm xs offset humeral head, 300-20-02, equinox square torque define screw drive kit, 300-50-45, 01270386 - 4.5mm short rep plate.

Event Description

As reported, this (b)(6) y/o male patient, 2 yrs postop the initial l tsa, the left humeral stem became loose and it revised was revised.We put in a long revision stem and the same size rep plate and head.Patient was last known to be in stable condition following the event.The device will not return due to facility policy.

Manufacturer Narrative

Section h10: (d4) serial number: (b)(6), expiration date: 26-dec-2028.(h3) the revision reported was likely the result of an insufficient bond between the humeral stem and the bone, which led to aseptic (non-infected) humeral loosening.However, this cannot be confirmed as the devices were not returned for evaluation and x-rays were not provided.(h4) device manufacture date: 31-dec-2018.

• Brand Name: EQUINOXE
• Type of Device: HUMERAL STEM PRIMARY PRESS FIT 12MM
• 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: 12604572
• MDR Text Key: 276910942
• Report Number: 1038671-2021-00524
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862283016
• UDI-Public: 10885862283016
• 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: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 300-01-12
• Device Catalogue Number: 300-01-12
• Device Lot Number: 117222010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/31/2018
• 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: 67 YR
• Patient Sex: Female