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

Model Number 314-13-13

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Failure of Implant (1924)

Event Date 06/21/2022

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.(concomitant device(s): 300-51-15, 5975584 - 1.5 short fa rep plt kit; 310-01-50, 5207937 - equinoxe, humeral head short, 50mm (beta).

Event Description

As reported, approximately 3 years post op the initial right tsa, this 67 y/o male patient was revised due to the glenoid failing.The poly became dissociated from the central and one of the peripheral pegs.Patient was last known to be in stable condition following the event.Device is not returning.

Manufacturer Narrative

Section h10: (h3) the revision reported in may have been the result of prosthesis fracture of the cage glenoid component which allowed for the pegs to separate from the glenoid body.Possible contributing factors include but are not limited to incomplete or off-axis seating of the glenoid component at the time of the implantation, and/or patient related conditions.However, this cannot be confirmed because the component was not returned for evaluation and radiographs were not provided.Section h11: the following sections have corrected information: (h6) component code: 4755, part/component/sub-assembly term not applicable.

• Brand Name: EQUINOXE CAGE GLENOID MEDIUM, BETA
• 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: 15029751
• MDR Text Key: 295988780
• Report Number: 1038671-2022-00798
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862172693
• UDI-Public: 10885862172693
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/27/2021
• Device Model Number: 314-13-13
• Device Catalogue Number: 314-13-13
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2016
• 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
• Treatment: SEE H10
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male