MAUDE Adverse Event Report: EXACTECH, INC. SMALL SUPERIOR AUGMENT GLENOID PLATE; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number	GLENOSPHERE, 36MM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Periprosthetic fracture (4902)
Date of Event	02/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a female patient, initial left shoulder implanted on (b)(6) 2024, underwent a revision procedure on (b)(6), 2024.The patient fractured her glenoid.No fall or accident occurred.The surgeon removed the baseplate, hat, reconstructed the glenoid, and implanted a competitor¿s baseplate and exactech tray and liner to match.There were no surgical delays or device breakages during the procedure.The patient was last known to be in stable condition following the event.An x-ray was provided.The explanted devices are not available for analysis.The surgeon kept them.No further information.
Additional Manufacturer Narrative
D10: concomitants: a699725 - 304-21-09 - 8.5mm platform fx stem left a496893 - 315-35-00 - glnd kwire 6898149 - 320-00-01 - 0 std left tray a791585 - 320-15-05 - eq rev locking screw a592211 - 320-20-00 - eq reverse torque defining screw kit s336580 - 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm s437460 - 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm s375722 - 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm a746504 - 320-35-02 - small superior augment glenoid plate a589552 - 320-36-00 - 145-deg pe 36mm hum liner +0 a826863 - 531-78-20 - shouldr gps hex pins kit additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: d1, d4, h4, h6.Mdr section codes updated/corrected: b, c, d, e, g.The revision reported was likely due to a bone fracture.The reason for the fracture 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: SMALL SUPERIOR AUGMENT GLENOID PLATE
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• 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: miguel sosa ; 2320 nw 66 court; gainesville, FL 32653 ; 3523782617
• MDR Report Key: 18882197
• Report Number: 1038671-2024-00461
• Device Sequence Number: 9256119
• Product Code: PHX
• UDI-Device Identifier: 10885862534873
• UDI-Public: 10885862534873
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K180632
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 08/01/2025

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: GLENOSPHERE, 36MM
• 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: 02/14/2024
• Supplement Date Received by Manufacturer: 07/31/2025
• Initial Report FDA Received Date: 03/11/2024
• Supplement Report FDA Received Date: 08/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2023
• 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