MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE GLENOID, PEGGED BETA, LARGE; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Catalog Number 314-02-14

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

Patient Problem Pain (1994)

Event Date 08/07/2023

Event Type  Injury  

Manufacturer Narrative

(d10) concomitant device(s): 300-01-15 - equinoxe, humeral stem primary, press fit 15mm 300-10-45 - equinoxe replicator plate 4.5mm o/s 310-01-50 - equinoxe, humeral head short, 50mm (beta).

Event Description

As reported by the equinoxe shoulder study, the 67-year-old white male had a right tsa on (b)(6) 2020.The patient present with unexplained pain on 08-07-2023.It was reported that the patient experienced sudden onset of pain and loss of function.The action taken for this event was other - x-ray and discussed at mdt.The outcome of this event is considered resolved on 01-05-2024.The case report form indicates that this event is unlikely related to the device and possibly related to the procedure.This event report was received through clinical data collection activities and no device return is anticipated.

• Brand Name: EQUINOXE GLENOID, PEGGED BETA, LARGE
• Type of Device: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• 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: matt collins ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19112872
• MDR Text Key: 340227552
• Report Number: 1038671-2024-00857
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10885862084521
• UDI-Public: 10885862084521
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K042021
• 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: 04/15/2024

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 Catalogue Number: 314-02-14
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/04/2024
• Initial Date FDA Received: 04/15/2024
• 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
• Treatment: SEE H10
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 94 KG
• Patient Race: White