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

Catalog Number 314-13-02

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 04/01/2024

Event Type  Injury  

Event Description

As reported, the 77 year old female patient had an initial right tsa on (b)(6)2016.The patient was revised on (b)(6)2024 due to a failed glenoid/disassociation.There was no reported breakage of a device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.No other patient information/medical history reported.

Manufacturer Narrative

D10: concomitants: 4356081 - 300-01-11 - equinoxe, humeral stem primary, press fit 11mm 2683993 - 300-10-15 - equinoxe replicator plate 1.5mm o/s 4177450 - 300-20-02 - equinox square torque define screw drive kit 3951189 - 310-01-41 - equinoxe, humeral head short, 41mm (alpha) 3868642 - 314-13-02 - equinoxe cage glenoid small, alpha 4333994 - 321-20-00 - equinoxe reverse shoulder drill kit h3:the revision reported was likely the result of fracture of the implant.The cause of fracture is generally a combination of risk factors including use error, implant positioning, implant size selection, and patient factors.However, this cannot be conclusively determined with the information provided.

• Brand Name: EQUINOXE CAGE GLENOID SMALL, ALPHA
• Type of Device: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH INC; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: matt collins ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19185842
• MDR Text Key: 341116896
• Report Number: 1038671-2024-00986
• Device Sequence Number: 1
• Product Code: KWS
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/19/2020
• Device Catalogue Number: 314-13-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/01/2024
• Initial Date FDA Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/23/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1412-2024
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Sex: Female