MAUDE Adverse Event Report: EXACTECH, INC. STEMLESS HUMERAL HEAD 50MM X 19MM X BETA; PROSTHESIS, TOTAL ANATOMIC SHOULDER, UNCEMENTED METAPHYSEAL HUMERAL STEM WITH NO

Catalog Number 310-61-50

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

Patient Problem Failure of Implant (1924)

Event Date 05/28/2020

Event Type  Injury  

Event Description

As reported by the equinoxe shoulder study, the patient had an initial tsa on (b)(6) 2020.The patient presented on (b)(6) 2020 with complains of persisting stiffness and discomfort after original arthroplasty - revised done on (b)(6) 2020.The case report form indicates that this event is definitely not related to device and definitely related to procedure.Outcome is resolved on (b)(6) 2020.

Manufacturer Narrative

(h3) pending evaluation.(d10) concomitant device(s): (b)(4) -stemless humeral comp integrip, cage, size 3.

• Brand Name: STEMLESS HUMERAL HEAD 50MM X 19MM 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; 2320 nw 66th ct.; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18196986
• MDR Text Key: 328888898
• Report Number: 1038671-2023-02842
• Device Sequence Number: 1
• Product Code: PKC
• UDI-Device Identifier: 10885862537126
• UDI-Public: 10885862537126
• 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: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/22/2023

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 Catalogue Number: 310-61-50
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/02/2023
• Initial Date FDA Received: 11/22/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/09/2019
• 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 Age: 46 YR
• Patient Sex: Male
• Patient Weight: 102 KG
• Patient Race: White