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

Model Number	300-01-12
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/21/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 1038671-2021-00524
• Device Sequence Number: 3586669
• Product Code: KWT
• UDI-Device Identifier: 10885862283016
• UDI-Public: 10885862283016
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K042021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2022

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
• Operator of Device: 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
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/21/2021
• Supplement Date Received by Manufacturer: 01/20/2022
• Initial Report FDA Received Date: 10/11/2021
• Supplement Report FDA Received Date: 02/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/31/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female