MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE CAGE GLENOID SMALL, ALPHA; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number 314-13-02

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 10/10/2022

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.Concomitant device(s): 3578593, 300-01-09 - equinoxe, humeral stem primary, press fit 9mm, 3651985, 300-10-45 - equinoxe replicator plate 4.5mm o/s, 3648429, 300-20-02 - equinox square torque define screw drive kit, 3611719, 310-01-41 - equinoxe, humeral head short, 41mm (alpha).

Event Description

It was reported that this female patient underwent a total shoulder replacement in 2014.During the following years, she suffered continued pain and underwent exploratory surgery in 2022.The surgeon found that the glenoid portion of the implant was discolored and delaminating and that pieces of the plastic had broken off the glenoid portion of the implant.The surgeon states that the glenoid portion will need to be replaced in the complaint months.

Manufacturer Narrative

Section h10: (e4) mw5112747.(g2) other: mw5112747.

Manufacturer Narrative

Section h10: (h3) the potential revision reported is likely the result of prosthesis wear as reported.However, the potential contributions from loosening, implant positioning, and/or patient-related issues to the reported event cannot be determined as the device remains implanted and limited information was provided.Section h11: *the following sections have corrected information: (h6) component code: 734, bearings.

• Brand Name: EQUINOXE CAGE GLENOID SMALL, ALPHA
• 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 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 15796617
• MDR Text Key: 303634501
• Report Number: 1038671-2022-01467
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862172679
• UDI-Public: 10885862172679
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/16/2019
• Device Model Number: 314-13-02
• Device Catalogue Number: 314-13-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2014
• 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 Outcome(s): Required Intervention
• Patient Sex: Female