MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 15MM; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Model Number 300-01-15

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

Patient Problem Bacterial Infection (1735)

Event Date 03/29/2023

Event Type  Injury  

Manufacturer Narrative

Pending investigation.D10: as reported, the male patient had an equinoxe stem and competitor's custom glenoid component implanted in her right shoulder in 2016 and multiple infections over the years.The patient was revised on (b)(6) 2023.Everything was removed and a spacer was placed in-situ.There was no reported breakage of 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.

Event Description

As reported, the male patient had an equinoxe stem and competitor's custom glenoid component implanted in her right shoulder in 2016 and multiple infections over the years.The patient was revised on (b)(6) 2023.Everything was removed and a spacer was placed in-situ.There was no reported breakage of 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

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.Correction to d10: 4573116 320-10-00 - equinoxe reverse tray adapter plate tray +0, 4494183 320-20-00 - eq reverse torque defining screw kit, 4494399 320-42-00 - equinoxe reverse 42mm humeral liner +0.

• Brand Name: EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 15MM
• Type of Device: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16782146
• MDR Text Key: 313707252
• Report Number: 1038671-2023-00779
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10885862079336
• UDI-Public: 10885862079336
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/29/2023

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 Model Number: 300-01-15
• Device Catalogue Number: 300-01-15
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/31/2023
• Initial Date Manufacturer Received: 03/31/2023
• Initial Date FDA Received: 04/20/2023
• Supplement Dates Manufacturer Received: 06/15/2023
• Supplement Dates FDA Received: 06/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2016
• 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: 66 YR
• Patient Sex: Male