MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE PRESERVE STEM 6MM; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Catalog Number 300-30-06

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 12/17/2020

Event Type  Injury  

Event Description

As reported by the equinoxe shoulder study, the patient had an initial left tsa on (b)(6)2018.The patient presented on (b)(6) 2020 with dislocation.The case report form indicates that this event is possibly related to device and/or to procedure.Outcome is resolved by revision on (b)(6) 2021.No device return anticipated due to being a clinical trial study.Ebi initial surgery attached.

Manufacturer Narrative

(h3) pending evaluation.(d10) concomitant device(s): 300-50-45 - 4.5mm short rep plate, (b)(6); 310-00-44 - xs humeral head, 44mm xs offset humeral head, (b)(6); 314-13-02 - equinoxe cage glenoid small, alpha, (b)(6).

• Brand Name: EQUINOXE PRESERVE STEM 6MM
• 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
• Manufacturer Contact: miguel sosa ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18419457
• MDR Text Key: 331615557
• Report Number: 1038671-2023-03076
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10885862515742
• UDI-Public: 10885862515742
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162726
• 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: 12/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 300-30-06
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/01/2018
• 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: 66 YR
• Patient Sex: Female
• Patient Weight: 75 KG
• Patient Race: White