MAUDE Adverse Event Report: EXACTECH, INC. MOLDED CAGE GLENOID LARGE, BETA; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number 314-23-14

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

Patient Problem Failure of Implant (1924)

Event Date 03/07/2024

Event Type  Injury  

Manufacturer Narrative

H3: pending investigation.D10: 300-01-14 - equinoxe humeral stem primary press fit 14mm : (b)(6).300-10-45 - equinoxe replicator plate 4.5mm o/s : (b)(6).300-20-02 - equinox square torque define screw drive kit : (b)(6).310-01-50 - equinoxe, humeral head short, 50mm (beta) : 6993233 319-01-32 - steinmann pin sterile 3.2mm x 178mm : 7314742 321-52-09 - 3.2mm k-wire, trocar tip : (b)(6).

Event Description

As reported by the equinoxe shoulder study, the 51-year-old non-hispanic white male had a left tsa on (b)(6) 2023.The patient present with unexplained pain on (b)(6) 2024.Reported shoulder pain (b)(6) 2024 - recommended pause pt with gentle stretching until evaluated.At three months visit (b)(6) 2024, felt range of motion was good but no strength.X-rays clear for periprosthetic fracture or lucency, with mild inferior subluxation of humeral head in relation to glenoid.Ct arthrogram and emg ordered.The outcome of this event is considered continuing.The case report form indicates that this event is possibly related to the device and/or to the procedure.This event report was received through clinical data collection activities and no device return is anticipated.

• Brand Name: MOLDED CAGE GLENOID LARGE, BETA
• Type of Device: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: matt collins ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19153068
• MDR Text Key: 340717854
• Report Number: 1038671-2024-00919
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 314-23-14
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/10/2023
• 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: 51 YR
• Patient Sex: Male
• Patient Weight: 111 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White