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

Catalog Number	320-15-08
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994); Periprosthetic fracture (4902)
Date of Event	09/08/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(h3) pending evaluation (d10) concomitant device(s): s395946 320-42-00 - 145-deg pe 42mm hum liner +0.A325296 300-30-12 - equinoxe preserve stem 12mm.A497936 320-10-00 - equinoxe reverse tray adapter plate tray +0.A499125 320-15-05 - eq rev locking screw.
Event or Problem Description
As reported by the equinoxe shoulder study, the patient had an initial right tsa on (b)(6) 2023.The patient presented on (b)(6) 2023 with a type 2 scapular spine fracture.The patient noticed increased pain after a sudden increase in activity to clean up after storm, acromion fracture with angulation.The case report form indicates that this event is unlikely related to device and definitely related to procedure.Outcome is continuing.Due to clinical study, no devices will be returned for evaluation.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: h6.Mdr section codes updated/corrected: a, b, c, d, e, g.The reason for the post operative bone fracture reported cannot be conclusively determined but may be related to implant positioning, patient bone quality, a trauma, and/or another patient related condition.However, this cannot be confirmed based on the information provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: 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: kate jacobson ; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18280344
• Report Number: 1038671-2023-02930
• Device Sequence Number: 6667388
• 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: 2023
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2025

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: 11/16/2023
• Supplement Date Received by Manufacturer: 08/05/2025
• Initial Report FDA Received Date: 12/07/2023
• Supplement Report FDA Received Date: 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2022
• 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.
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White