MAUDE Adverse Event Report: EXACTECH, INC. UHMWPE POST AUG GLENOID MEDIUM, LEFT; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	UHMWPE POST AUG GLENOID MEDIUM, LEFT
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomittants: 4319721 300-10-15 - equinoxe replicator plate 1.5mm o/s; 4304260 / 310-01-47 - equinoxe, humeral head short, 47mm (beta); 4319721 / 300-10-15 - equinoxe replicator plate 1.5mm o/s; 4364756 / 300-01-11 - equinoxe, humeral stem primary, press fit 11mm; 4372171 / 315-35-00 - glnd kwire; 4413865 / 300-20-02 - equinox square torque define screw drive kit.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
While investigating a 2023 revision for this patient, it was found that a 63 yo male patient had a prior revision on (b)(6) 2018.No further information known.
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, g1, g4, h4, h6.Mdr section codes updated/corrected: a, b, c, d, g.The reason for the revision reported in cannot be confirmed from the information provided but may be due to inclusion of the polyethylene in the packaging recall, wear, loosening, infection, fracture, instability, dislocation, rotator cuff tear, and/or patient related factors.Potential contributions of manufacturing, user, and patient-related considerations to the event could not be assessed as the devices were not available for evaluation images, radiographs, and relevant clinical information were 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: UHMWPE POST AUG GLENOID MEDIUM, LEFT
• 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, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18268505
• Report Number: 1038671-2023-02910
• Device Sequence Number: 3890744
• Product Code: KWS
• UDI-Device Identifier: 10885862175069
• UDI-Public: 10885862175069
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K103419
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• 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): 09/03/2025

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 Expiration Date: 04/15/2019
• Device Model Number: UHMWPE POST AUG GLENOID MEDIUM, LEFT
• Device Catalogue Number: 314-02-23
• 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: 11/09/2023
• Supplement Date Received by Manufacturer: 09/02/2025
• Initial Report FDA Received Date: 12/05/2023
• Supplement Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2014
• Is the Device Labeled for Single Use? (Y/N): No
• 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 Age: 63 YR
• Patient Sex: Male