MAUDE Adverse Event Report: EXACTECH, INC. STEMLESS HUMERAL HEAD 47MM X 18MM X BETA; PROSTHESIS, TOTAL ANATOMIC SHOULDER, UNCEMENTED METAPHYSEAL HUMERAL STEM WITH NO

Model Number STEMLESS HUMERAL HEAD 47MM X 18MM X BETA

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Failure of Implant (1924)

Event Date 03/19/2024

Event Type  Injury  

Event Description

As reported, approximately four months post initial right tsa, the 63 y/o male had a revision to remove existing stemless humeral implants and revise to stemmed humeral implant and anatomic glenoid component.The patient had the stemless humeral head and cage removed and an equinoxe humeral stem was implanted along with a laser cage glenoid.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Sales rep was unable to obtain photo/x-rays.The devices are not available for evaluation due to hospital retains the explanted products.

Manufacturer Narrative

Section d10: concomitant products : stemless humeral cage size 3.(cat# 300-60-03 / serial# (b)(6)).Additional information, including the product investigation, will be submitted within 30 days of receipt.

• Brand Name: STEMLESS HUMERAL HEAD 47MM X 18MM X BETA
• Type of Device: 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 66 court; gainesville FL 32653
• Manufacturer Contact: matt collins
• MDR Report Key: 19185042
• MDR Text Key: 341114943
• Report Number: 1038671-2024-00985
• Device Sequence Number: 1
• Product Code: PKC
• UDI-Device Identifier: 10885862537119
• UDI-Public: 10885862537119
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173388
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/25/2024

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
• Device Operator: Health Professional
• Device Model Number: STEMLESS HUMERAL HEAD 47MM X 18MM X BETA
• Device Catalogue Number: 310-61-47
• Device Lot Number: 402625003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/19/2024
• Initial Date FDA Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male