MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; CAGE GLENOID M, POST AUG, RIGHT

Model Number 314-13-33

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Failure of Implant (1924)

Event Date 07/27/2021

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

As reported, approximately 3 yrs postop the initial rtsa, this (b)(6) male patient presented with pain in shoulder.X-rays revealed a failed caged glenoid with pegs not in proper orientation.Surgeon proceeded to remove caged glenoid and retained humeral components.He left the patient with a hemi arthroplasty.Patient left or stable and is expected to make a full recovery.Devices will not return due to facility policy.

Manufacturer Narrative

(h3) the revision reported may have been due to an insufficient bond between the cage glenoid component and the bone, which led to aseptic (non-infected) glenoid loosening, improper implantation during the index surgery, or a combination of the two, which resulted in the cage glenoid¿s pegs not being in the proper orientation.However, this cannot be confirmed as the device was not returned for evaluation and radiographs were not provided.

• Brand Name: EQUINOXE
• Type of Device: CAGE GLENOID M, POST AUG, RIGHT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 12317958
• MDR Text Key: 266371832
• Report Number: 1038671-2021-00386
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862201010
• UDI-Public: 10885862201010
• Combination Product (y/n): N
• PMA/PMN Number: K113309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2023
• Device Model Number: 314-13-33
• Device Catalogue Number: 314-13-33
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 68 YR