MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; CAGE GLENOID LARGE, ALPHA

Model Number 314-13-04

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bacterial Infection (1735)

Event Date 04/01/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant device(s): 300-01-11, equinoxe, humeral stem primary, press fit 11mm.310-01-44, equinoxe, humeral head short, 44mm (alpha).300-50-15, 1.5mm short rep plate.

Event Description

Approximately 3 years postop the initial l tsa, the patient fell about 6 months ago, but noticed a severe increase in pain in shoulder 2-3months ago.Was diagnosed with septic loosening and was set up with 2 stage revision with antibiotic spacer first.Outcome reported as continuing.

Manufacturer Narrative

Section h10: (h3) based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the infection and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.

• Brand Name: EQUINOXE
• Type of Device: CAGE GLENOID LARGE, ALPHA
• 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: 12553392
• MDR Text Key: 273984135
• Report Number: 1038671-2021-00501
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862172709
• UDI-Public: 10885862172709
• 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: 04/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 314-13-04
• Device Catalogue Number: 314-13-04
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 56 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White