MAUDE Adverse Event Report: Exactech, Inc. STEMLESS HUMERAL COMP INTEGRIP, CAGE, SIZE 3; Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No

Catalog Number	300-62-03
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Joint Dislocation (2374); Aseptic loosening (4883)
Date of Event	08/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a left shoulder replacement.Subsequently, the patient developed shoulder pain following an episode of locking while swimming breaststroke.The patient had been functioning well prior to this event.Radiographs confirmed loosening of the stemless humeral component.The surgeon removed the humeral components without complication.The glenoid component was found to be well fixed in situ; however, minor wear and fraying of the polyethylene was noted along the posterior edge, consistent with a posterior dislocation event.The consultant removed frayed polyethylene to reduce the risk of further fragmentation and intra-articular entrapment and left the glenoid component in situ.The humeral components were revised to stemmed anatomic components.A slightly oversized humeral head was implanted to increase joint stability.Postoperatively, imaging was satisfactory.Samples were obtained and remained pending at the time of reporting.The consultant did not suspect an infectious etiology.The patient was last known to be in stable condition following the event.No further information is available.

• Brand Name: STEMLESS HUMERAL COMP INTEGRIP, CAGE, SIZE 3
• 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; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: julia goldberg ; 2320 nw 66 ct; gainesville, FL 32653 ; +1(352)377-1140
• MDR Report Key: 50412475
• Report Number: 1038671-2026-01074
• Device Sequence Number: 13049501
• Product Code: PKC
• UDI-Device Identifier: 10885862536761
• UDI-Public: 10885862536761
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K173388
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• 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): 08/24/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 300-62-03
• 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: Not provided
• Initial Report FDA Received Date: 08/24/2026
• Date Device Manufactured: 06/20/2025
• 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: Unknown