MAUDE Adverse Event Report: Exactech, Inc. STEMLESS HUMERAL HEAD 50MM X 16MM X BETA; Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No

Catalog Number	310-62-50
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Joint Impingement (4834)
Date of Event	12/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial shoulder replacement.Subsequently, the patient experienced pain and sub-acromial impingement without injury.As a result, the patient received a subacromial corticosteroid injection two weeks after onset of symptoms.No further patient impact reported.No further information available.

• Brand Name: STEMLESS HUMERAL HEAD 50MM X 16MM X BETA
• Common Device Name: Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No
• Manufacturer (Section D): Exactech, Inc.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): Exactech, Inc.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: julia goldberg ; 2320 nw 66th ct; gainesville, FL 32653 ; +1 (352) 377-1140
• MDR Report Key: 50567108
• Report Number: 1038671-2026-01130
• Device Sequence Number: 13288043
• Product Code: PKC
• UDI-Device Identifier: 10885862556141
• UDI-Public: 10885862556141
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K173388
• 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: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/02/2026

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: 310-62-50
• 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: 02/25/2024
• Initial Report FDA Received Date: 09/02/2026
• Date Device Manufactured: 01/26/2022
• 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: Required Intervention; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 170 LB
• Patient Race: White