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

Catalog Number 314-13-03

Device Problem Naturally Worn (2988)

Patient Problem Failure of Implant (1924)

Event Date 03/28/2024

Event Type  Injury  

Event Description

As reported, the 71 year old female patient had an initial right tsa on (b)(6) 2019.The patient was revised on (b)(6) 2024 due to a failed glenoid.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.

Manufacturer Narrative

Section h10: (h3) pending evaluation.(d10) concomitant device(s): 531-78-20 - shouldr gps hex pins kit 6265431.A10012 - gps implant kit v2 10000219262.300-01-09 - equinoxe, humeral stem primary, press fit 9mm 6119646.300-20-02 - equinox square torque define screw drive kit 6104214.300-50-15 - 1.5mm short rep plate 5293116.310-00-47 - xs humeral head, 47mm xs offset humeral head 5289479.

• Brand Name: EQUINOXE CAGE GLENOID MEDIUM, 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; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: matt collins ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19177881
• MDR Text Key: 341001428
• Report Number: 1038671-2024-00972
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862172686
• UDI-Public: 10885862172686
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/24/2024

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: 05/01/2023
• Device Catalogue Number: 314-13-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/01/2024
• Initial Date FDA Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/02/2018
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female