MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE 46MM HUMERAL LINER +0; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number 320-46-00

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 12/28/2017

Event Type  Injury  

Event Description

As reported by the equinoxe shoulder study, the patient, (b)(6), had an initial left tsa on (b)(6) 2017.Patient (b)(6) presented on (b)(6) 2017 with instability described as having subluxation that are self-reduced.The case report form indicates that this event is possibly related to device and definitely related to procedure.Outcome is continuing; patient advised to schedule revision (poly exchange).Due to clinical study, no devices will be returned for evaluation.

Manufacturer Narrative

(h3) pending evaluation: (d10) concomitant device(s): 320-01-46 - equinoxe reverse 46mm glenosphere: (b)(6).300-30-12 - equinoxe preserve stem 12mm: (b)(6).320-10-00 - equinoxe reverse tray adapter plate tray +0: (b)(6).320-15-01 - eq rev glenoid plate: (b)(6).

• Brand Name: EQUINOXE REVERSE 46MM HUMERAL LINER +0
• 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; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: miguel sosa ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18358647
• MDR Text Key: 330905278
• Report Number: 1038671-2023-03029
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086730
• UDI-Public: 10885862086730
• 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: 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/07/2021
• Device Catalogue Number: 320-46-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/09/2016
• 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: 59 YR
• Patient Sex: Male
• Patient Weight: 95 KG
• Patient Race: White