MAUDE Adverse Event Report: EXACTECH, INC. LASER CAGE GLENOID MEDIUM, BETA; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	314-23-13
Date of Event	11/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial tsa (total shoulder arthroplasty) on the right side.Subsequently, the patient was revised due to pain and loosening of the glenoid component.Patient was revised to exactech devices.Patient was last known to be in stable condition following the event.No further information available.
Additional Manufacturer Narrative
D10: 300-01-11 - equinoxe, humeral stem primary, press fit 11mm (b)(6).300-10-45 - equinoxe replicator plate 4.5mm o/s (b)(6).300-20-02 - equinox square torque define screw drive kit (b)(6).310-01-47 - equinoxe, humeral head short, 47mm (beta) (b)(6).(b)(6).Gps implant kit v2 04000523151.The reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.Operative notes and/or medical records were not provided for review of usage/technique.A definitive root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: LASER CAGE GLENOID MEDIUM, BETA
• 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 66 ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 23816326
• Report Number: 1038671-2025-03561
• Device Sequence Number: 10098729
• Product Code: KWS
• UDI-Device Identifier: 10885862585318
• UDI-Public: 10885862585318
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/16/2025

1 Device was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 314-23-13
• 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: 11/25/2025
• Initial Report FDA Received Date: 12/16/2025
• Date Device Manufactured: 05/08/2023
• 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