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
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/28/2020
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• 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 66th ct.; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18196986
• Report Number: 1038671-2023-02842
• Device Sequence Number: 6403423
• Product Code: PKC
• UDI-Device Identifier: 10885862537126
• UDI-Public: 10885862537126
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K173388
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Catalogue Number: 310-61-50
• 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: 11/02/2023
• Initial Report FDA Received Date: 11/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/09/2019
• 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
• Patient Age: 46 YR
• Patient Sex: Male
• Patient Weight: 102 KG
• Patient Race: White