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

Catalog Number 314-13-13

Device Problem Naturally Worn (2988)

Patient Problem Failure of Implant (1924)

Event Date 09/06/2023

Event Type  Injury  

Manufacturer Narrative

Section h10: (h3) pending evaluation (d10) concomitant device(s): 310-01-47 - equinoxe, humeral head short, 47mm (beta) 2946854.300-01-13 - equinoxe, humeral stem primary, press fit 13mm 2979013.300-20-02 - equinox square torque define screw drive kit 3534168.300-10-45 - equinoxe replicator plate 4.5mm o/s 3641528.

Event Description

The glenoid component was not broken or loose.I'm guessing the patient's rc had deteriorated and was unstable, or maybe the nine-year-old poly was starting to wear.

• 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
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 17859771
• MDR Text Key: 324775316
• Report Number: 1038671-2023-02440
• 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
• Report Date: 10/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/15/2018
• Device Catalogue Number: 314-13-13
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/25/2013
• 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 Age: 60 YR
• Patient Sex: Male