MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; CAGE GLENOID MEDIUM, ALPHA

Catalog Number 314-13-03

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Failure of Implant (1924)

Event Date 10/14/2021

Event Type  Injury  

Manufacturer Narrative

Pending evaluation concomitant device(s): humeral head.

Event Description

Approximately 9 yrs postop the initial rtsa, this (b)(6) female patient underwent a revision of the anatomical shoulder to reverse shoulder was completed, due to glenoid wear and rotator cuff insufficient.The cage glenoid and humeral head.Replaced with a 38 glenoid standard cage.With a 2.5 liner and zero tray.Patient was last known to be in stable condition following the event.Devices will not return due to surgeon¿s request.

Manufacturer Narrative

Section h10: (d4) catalog number: 314-13-03, serial number: (b)(6), expiration date: 11-jul-2017, unique identifier (udi) #: (b)(4).(g4) pma/510(k)number: k113309.(h3) the revision reported was likely the result of prosthesis wear and an insufficient rotator cuff.However, this cannot be confirmed as the devices were not returned for evaluation.Additional contributions of implant alignment, glenoid loosening, and patient-related conditions as well as the sequence of events leading to the revision cannot be determined from the information provided.(h4) device manufacture date: 12-jul-2012 section h11: *the following sections have corrected information: (d11) concomitant device(s): 300-10-15, 2494735 - equinoxe replicator plate 1.5mm o/s, 300-20-02, 2504551 - equinox square torque define screw drive kit, 310-01-44, 2506040 - equinoxe, humeral head short, 44mm (alpha).

• Brand Name: EQUINOXE
• Type of Device: CAGE GLENOID MEDIUM, ALPHA
• 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: 12745762
• MDR Text Key: 279876926
• Report Number: 1038671-2021-00575
• Device Sequence Number: 1
• Product Code: KWT
• 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: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/11/2017
• Device Catalogue Number: 314-13-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2012
• 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): Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female