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

Model Number	UHMWPE POST AUG GLENOID LARGE, RIGHT
Medical Device Problem Codes	Fracture (1260); Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: (b)(6) - 300-01-15 - equinoxe, humeral stem primary, press fit 15mm.(b)(6) - 300-10-15 - equinoxe replicator plate 1.5mm o/s.(b)(6) - 300-20-02 - equinox square torque define screw drive kit.(b)(6) - 310-02-50 - equinoxe, humeral head tall, 50mm (beta).(b)(6) - 314-02-34 - uhmwpe post aug glenoid large, right.(b)(6) - 315-35-00 - glnd kwire.(b)(6) - 315-35-00 - glnd kwire.
Event or Problem Description
It was reported that a male patient, initial shoulder implanted on (b)(6) 2012, underwent a revision procedure on (b)(6) 2024, approximately 11 years 9 months post the initial procedure.The patient was converted from an anatomic to a reverse with a competitor¿s custom glenoid.Exactech tray and liner was implanted with the existing stem.There were no device breakages or surgical delays during the procedure.The patient was last known to be in stable condition following the event.An x-ray was provided.No explanted devices are available for return.The hospital kept them.Device images were provided.No further information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The reason for the revision reported was likely due to prothesis wear caused by rotator cuff insufficiencies, relative positioning of implants, and/or the inclusion of the polyethylene in the packaging recall.Additionally, this glenoid component appears to have been implanted over ten years prior to the reported event.However, the cause of the wear can not be confirmed from the provided information as the device was not returned for evaluation.Potential user and patient-related considerations to the event could not be assessed from the provided information.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 LARGE, RIGHT
• 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: matt collins ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19160960
• Report Number: 1038671-2024-00940
• Device Sequence Number: 20696951
• Product Code: KWS
• UDI-Device Identifier: 10885862175113
• UDI-Public: 10885862175113
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K103419
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• 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): 03/17/2025

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: 02/09/2016
• Device Model Number: UHMWPE POST AUG GLENOID LARGE, RIGHT
• Device Catalogue Number: 314-02-34
• 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: 03/31/2024
• Supplement Date Received by Manufacturer: 03/14/2025
• Initial Report FDA Received Date: 04/22/2024
• Supplement Report FDA Received Date: 03/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2011
• 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: Male