MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE SUP/POST AUG PLATE, R RS GLENOID BASEPLATE; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-15-08
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	08/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(d10): concomitant device(s): 315-35-00 - glnd kwire (b)(6).320-02-42 - rs expanded glenosphere 42mm, +4mm offset: (b)(6).320-10-05 - equinoxe reverse tray adapter plate tray +5: (b)(6).320-15-05 - eq rev locking screw: (b)(6).320-20-00 - eq reverse torque defining screw kit: (b)(6).320-42-03 - equinoxe reverse 42mm humeral liner +2.5: (b)(6).
Event or Problem Description
Approximately 5 year(s) and 2 day(s) post-operative of a revised right rtsa, it was reported via clinical study that the patient experienced septic loosening.It was further stated; failed baseplate of revision rtsa with gross purulence.In the earlier revision, the patient experienced instability and dislocation that was resolved with the removal of the humeral tray, humeral liner, glenosphere, and glenosphere locking screw.The patient underwent another standard reverse revision with the removal of the standard humeral stem, torque screw, humeral tray, humeral liner, glenosphere, glenosphere locking screw, glenoid base plate, and compression screw/locking cap.The outcome of this event is considered resolved and the clinical report indicates that this event is unlikely related to the device(s) and definitely related to the procedure.

• Brand Name: EQUINOXE SUP/POST AUG PLATE, R RS GLENOID BASEPLATE
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 20402788
• Report Number: 1038671-2024-03876
• Device Sequence Number: 20462488
• Product Code: KWS
• UDI-Device Identifier: 10885862242563
• UDI-Public: 10885862242563
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K131575
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/08/2024

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 Catalogue Number: 320-15-08
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2024
• Initial Report FDA Received Date: 10/08/2024
• Date Device Manufactured: 02/01/2017
• 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 H11.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 98 KG
• Patient Race: White