MAUDE Adverse Event Report: EXACTECH, INC. STEMLESS HUMERAL HEAD 47MM X 15MM X BETA; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	310-62-47
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this patient's right shoulder was revised.Patient had pain that lead to x-rays.Observation showed migration on the pe and the peripheral pegs.Only the central peg was still in place, it was initially cemented.The patient was converted to a reverse with a baseplate+10mm and bone graft.Patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
H3: the revision reported was likely the result of the glenoid loosening and fracture of the center cage leading to migration and wear of the polyethylene body.However, the reason for the loosening and fracture could not be confirmed, and contributions from incomplete/improper seating of the device and patient-related considerations to the event could not be assessed from the information provided.The observed damage and wear on the articular surface of the glenoid component may have been due to contact with the humeral bone and/or damage following migration of the glenoid component.The observed wear on the humeral head was likely due to unintended contact with the retained center cage following fracture of the center polyethylene peg and subsequent migration of the glenoid body.

• Brand Name: STEMLESS HUMERAL HEAD 47MM X 15MM X 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 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 21855972
• Report Number: 1038671-2025-01846
• Device Sequence Number: 4721441
• Product Code: KWS
• UDI-Device Identifier: 10885862556134
• UDI-Public: 10885862556134
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/17/2025

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 Catalogue Number: 310-62-47
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2024
• Initial Report FDA Received Date: 04/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Male
• Patient Weight: 65 KG