MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	320-10-00
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/15/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, after an unknown amount of time from the primary left tsa surgery, this (b)(6) y/o male patient's left humeral liner separated from the humeral tray.The surgeon removed the preserve stem, zero humeral tray, 46 neutral humeral liner and 46 inset glenosphere and was replaced with a 42+4 glenosphere.There was ¿no breakage or surgical delay¿.Patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
Device evaluated by manufacturer? pending evaluation.Concomitant medical device(s): 320-02-46, 256701013 - 46x21mm glenosphere high moment arm.46 zero humeral liner.Size 6 preserve stem.
Additional Manufacturer Narrative
Section h10: (h3) the revision reported was likely the result of incomplete seating of the liner during implantation, bone impingement, patient-related conditions, or any combination of these possibilities, which led to humeral liner disassociation.Section h11: *the following sections have corrected information: (d2b) common device name: prosthesis, shoulder, non-constrained, metal/polymer cemented (d4) catalog number: 320-46-00, serial number: (b)(6), expiration date: 26-mar-2022, unique identifier (udi) #: (b)(4).(d11) concomitant device(s): 300-30-06, (b)(6) - equinoxe preserve stem 6mm.320-02-46, (b)(6) - 46x21mm glenosphere high moment arm.320-10-00, (b)(6) - equinoxe reverse tray adapter plate tray +0.320-15-05, (b)(6) - eq rev locking screw.320-20-00, (b)(6) - eq reverse torque defining screw kit.

• Brand Name: EQUINOXE
• Common Device Name: 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 32605
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 12933345
• Report Number: 1038671-2021-00659
• Device Sequence Number: 20030603
• Product Code: KWT
• UDI-Device Identifier: 10885862086730
• UDI-Public: 10885862086730
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2022

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 Expiration Date: 03/26/2022
• Device Model Number: 320-10-00
• Device Catalogue Number: 320-46-00
• Device Lot Number: 06114677
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/16/2021
• Supplement Date Received by Manufacturer: 05/31/2022
• Initial Report FDA Received Date: 12/06/2021
• Supplement Report FDA Received Date: 06/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2017
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 83 KG