MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE CAGE GLENOID S, POST AUG, RIGHT; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Model Number	314-13-32
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/22/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported via legal notification, the patient had an initial right tsa with capsular release on (b)(6) 2019.In may 2021 the patient had increasing pain and lost all functional use of her right arm.Radiographs were consistent with a catastrophic failure of the glenoid component with severe glenoid bone loss, left shoulder pain, and partial thickness rotator cuff tear.The decision was made to proceed with a revision.On or about (b)(6) 2021, the surgeon performed the first of a two-stage procedure with a custom glenoid implant.The surgeon performed a right shoulder removal of the loose glenoid component, right shoulder removal of the well-fixed central glenoid cage, right shoulder synovial biopsy, right shoulder extensive debridement and resection of metallosis, right shoulder removal of loose peripheral pegs, right shoulder bone grafting to the glenoid and proximal humerus, and right shoulder revision of the humeral component with exchange of the replicator plate and humeral head.The pre and post-op diagnosis included right shoulder catastrophic failure glenoid prosthesis.On or about (b)(6) 2021, the surgeon performed the second stage of the two-stage procedure.The surgery included a right revision reverse total shoulder arthroplasty with humeral component exchange and glenosphere exchange.The post-operative diagnosis was right shoulder failed reverse tsa with dislocated polyethylene component.
Additional Manufacturer Narrative
Pending investigation.D10: 5933903, 300-01-11 - equinoxe, humeral stem primary, press fit 11mm.5813677, 300-10-45 - equinoxe replicator plate 4.5mm o/s.5917635, 300-20-02 - equinox square torque define screw drive kit.5546430, 310-01-44 - equinoxe, humeral head short, 44mm (alpha).4269897, 314-13-32 - equinoxe cage glenoid s, post aug, right.2029019143, a10012 - gps implant k.

• Brand Name: EQUINOXE CAGE GLENOID S, POST AUG, RIGHT
• Common Device Name: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16941217
• Report Number: 1038671-2023-01004
• Device Sequence Number: 20723437
• Product Code: HSD
• UDI-Device Identifier: 10885862201003
• UDI-Public: 10885862201003
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K113309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/16/2023

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: 02/07/2021
• Device Model Number: 314-13-32
• Device Catalogue Number: 314-13-32
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/16/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2023
• Initial Report FDA Received Date: 05/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/10/2016
• 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
• Patient Sex: Female