MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE, HUMERAL HEAD EXPANDED, 53MM (BETA); PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Catalog Number 310-03-53

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 02/07/2023

Event Type  Injury  

Manufacturer Narrative

(d10) concomitant device(s): 300-10-45 - equinoxe replicator plate 4.5mm o/s: a188948; 300-20-02 - equinox square torque define screw drive kit: a090781, 321-20-00 - equinoxe reverse shoulder drill kit: a181278.(h3) pending evaluation.

Event Description

As reported by the equinoxe shoulder study, the 64-year-old male patient had a left tsa on (b)(6) 2022.The patient presented with a instability / subluxation on (b)(6) 2023.Shoulder continued to subluxate post-operatively, especially at night.Patient also developed a fistula and a draining sinus.This event is related to (b)(4).The outcome of this event is considered resolved on (b)(6) 2023 by the action of revision.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: EQUINOXE, HUMERAL HEAD EXPANDED, 53MM (BETA)
• 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: 19009221
• MDR Text Key: 338980205
• Report Number: 1038671-2024-00693
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10885862083999
• UDI-Public: 10885862083999
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063569
• 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: 03/30/2024

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: 310-03-53
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2024
• Initial Date FDA Received: 03/30/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/07/2020
• 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: 64 YR
• Patient Sex: Male
• Patient Weight: 116 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White