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

Model Number	EXPANDED GLENOSPHERE, 36MM, FOR SMALL REVERSE
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Periprosthetic fracture (4902)
Date of Event	09/12/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an over 75 yo female patient, who had an initial shoulder procedure on (b)(6) 2022, suffered an acromial stress fracture.The surgeon exchanged the glenosphere, glenosphere locking screw, humeral tray, torque screw and humeral liner to detention the patient.The patient had 25 degrees of glenoid retroversion.The surgeon used an augmented base plate and expanded glenosphere to correct version and maintain joint tension.In hindsight he regrets lateralizing her with the expanded option and thinks he may have over tensioned her leading to the acromial fracture.There was no direct trauma to the shoulder.The patient had a low bmi and was relatively healthy considering her age.The patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
No device returning as the hospital disposed of it.Concomitants: 300-01-11 - equinoxe, humeral stem primary, press fit 11mm 7311586, 320-10-00 - equinoxe reverse tray adapter plate tray +0 7316700, 320-15-05 - eq rev locking screw 7312244, 320-20-00 - eq reverse torque defining screw kit 7294616, 320-35-04 - small posterior augment glenoid plate, right 7033769, 320-36-00 - 36mm humeral liner +0 unconstrained 7223562, based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of surgical revision for acromial stress fracture cannot be conclusively determined; however, it is most likely related to patient condition and the procedure.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b3, d1, d4, d6b, g4, h4, h6: clinical code, medical device problem code, component code, type of investigation, investigation findings, investigation conclusions.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: SMALL POSTERIOR AUGMENT GLENOID PLATE, RIGHT
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 15571392
• Report Number: 1038671-2022-01280
• Device Sequence Number: 14148378
• Product Code: KWS
• UDI-Device Identifier: 10885862534897
• UDI-Public: 10885862534897
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K180632
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2025

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 Model Number: EXPANDED GLENOSPHERE, 36MM, FOR SMALL REVERSE
• Device Catalogue Number: 320-35-04
• 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: 09/13/2022
• Supplement Date Received by Manufacturer: 11/05/2025
• Initial Report FDA Received Date: 10/10/2022
• Supplement Report FDA Received Date: 11/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female