MAUDE Adverse Event Report: EXACTECH, INC. SMALL SUPERIOR AUGMENT GLENOID PLATE; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-35-02
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580); Aseptic loosening (4883)
Date of Event	05/31/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant device(s): 300-01-11 - equinoxe, humeral stem primary, press fit 11mm: 6168975.315-35-00 - glnd kwire: 5903106.320-10-05 - equinoxe reverse tray adapter plate tray +5: 6186576.320-15-05 - eq rev locking screw: 6209183.320-20-00 - eq reverse torque defining screw kit: 6224106.320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm: 6225730.320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm: 6080509.320-35-02 - small superior augment glenoid plate: 5955433.320-40-03 - humeral liner, 40mm, +2.5: 5813540.
Event or Problem Description
As reported by the equinoxe shoulder study, the 69-year-old male patient had an initial left tsa on (b)(6)2019 and presented with aseptic glenoid loosening on (b)(6)2024.The outcome of this event is considered continuing and with no action taken.The case report form indicates that this event is unlikely related to the device and definitely related to the procedure.This event report was received through clinical data collection activities and no device return is anticipated.
Additional Manufacturer Narrative
After further review of additional information received the following sections a2, b5, d1, d2a, d2b, d4, d6b, d10, h1 and h6 have been updated accordingly.Concomitant devices: 320-10-05 - equinoxe reverse tray adapter plate tray +5: (b)(6).320-32-40 - expanded glenosphere, 40mm, for small reverse: (b)(6).300-01-11 - equinoxe, humeral stem primary, press fit 11mm: (b)(6).315-35-00 - glnd kwire: (b)(6).320-15-05 - eq rev locking screw: (b)(6).320-20-00 - eq reverse torque defining screw kit: (b)(6).320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm: (b)(6).320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm: (b)(6).320-40-03 - humeral liner, 40mm, +2.5: (b)(6).
Event or Problem Description
As reported by the equinoxe shoulder study, approximately 4 years, 2 months, and 15 days post-operatively of an initial rtsa, the patient presented with aseptic glenoid loosening.X-ray shows rtsa baseplate failure without increase in pain or trauma; subject was last seen in 2021.The patient underwent revision surgery and the outcome of this event is now considered resolved.The clinical report indicates that this event is unlikely related to the device and definitely related to the procedure.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: b3, d1/d2a/d2b, d4, h6.Mdr section codes updated/corrected: b, c, d, e, g.The reason for the revision reported cannot be confirmed from the information provided but may be the result of aseptic glenoid loosening.However, the loosening cannot be confirmed and potential contributions of user or patient-related considerations could not be assessed as the component was not returned for evaluation and no images, radiographs, or relevant clinical information were provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: SMALL SUPERIOR AUGMENT GLENOID PLATE
• 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: miguel sosa ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18763374
• Report Number: 1038671-2024-00307
• Device Sequence Number: 7906884
• Product Code: KWS
• UDI-Device Identifier: 10885862534873
• UDI-Public: 10885862534873
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K180632
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/30/2025
• 2 Devices were Involved in the Event: 1 2

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: 320-35-02
• 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: 01/23/2024
• Supplement Date Received by Manufacturer: Not provided; 04/29/2025
• Initial Report FDA Received Date: 02/22/2024
• Supplement Report FDA Received Date: 08/26/2024; 04/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2019
• 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; SEE H11
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 97 KG
• Patient Race: White