MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; SMALL EXTENDED CAGE GLENOID PLATE

Model Number	320-32-36
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/14/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant device(s): 306-01-08, equinoxe, humeral long stem 8mm 175mm; 320-36-03, 36mm humeral liner +2.5mm unconstrained; 320-10-00, equinoxe reverse tray adapter plate tray +0; 320-35-06, small extended cage glenoid plate.
Event or Problem Description
As reported, approximately 1 yr.Postop the implanted ltsa and entered this clinical study, this (b)(6) female patient who had a history of infections in prior implanted devices (manufacturers unknown) presented with aseptic glenoid loosening.Radiographs showed aseptic glenoid loosening and that the bone graft had not incorporated.The surgeon opted to do a staged revision with bone grafting of the iliac crest to the glenoid followed by a revision to a reverse tsa.The first procedure (removal of components, bone grafting, and placing antibiotic spacers) was performed on (b)(6) 2021.The conversion to a reverse tsa was performed on (b)(6) 2021.The patient was an inpatient for 2 days and discharged home.This event was reported as resolved on (b)(6) 2021.The case report form indicates this event is not related to devices and definitely related to the procedure.This event report was received through clinical data collection activities.
Additional Manufacturer Narrative
Section h10: (d4) serial number: (b)(6), expiration date: 07-may-2029, (h3) the revision reported was likely the result of both patient conditions and an insufficient bond between the glenoid baseplate and the bone, which led to aseptic (non-infected) glenoid loosening.However, this cannot be confirmed as the devices and x-rays were not available for evaluation.Section h11: *the following sections have corrected information: (d2b) common device name: small extended cage glenoid plate (d4) catalog number: 320-35-06, unique identifier (udi) #: (b)(4).(d11) concomitant device(s): 320-36-03 - 36mm humeral liner +2.5mm unconstrained (b)(6).320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm (b)(6).306-01-08 - equinoxe, humeral long stem 8mm 175mm (b)(6).320-32-36 - expanded glenosphere, 36mm, for small reverse (b)(6).321-20-00 - equinoxe reverse shoulder drill kit (b)(6).320-20-00 - eq reverse torque defining screw kit (b)(6).320-10-00 - equinoxe reverse tray adapter plate tray +0 (b)(6).320-15-05 - eq rev locking screw (b)(6).320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm (b)(6).320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm (b)(6).320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm (b)(6).

• Brand Name: EQUINOXE
• Common Device Name: SMALL EXTENDED CAGE GLENOID PLATE
• 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: 12736810
• Report Number: 1038671-2021-00567
• Device Sequence Number: 11129667
• Product Code: KWT
• UDI-Device Identifier: 10885862534903
• UDI-Public: 10885862534903
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K180632
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2022

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: 320-32-36
• Device Catalogue Number: 320-35-06
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/13/2021
• Supplement Date Received by Manufacturer: 02/25/2022
• Initial Report FDA Received Date: 11/02/2021
• Supplement Report FDA Received Date: 03/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White