MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 9MM; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Model Number 300-01-09

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

Patient Problem Bacterial Infection (1735)

Event Date 03/18/2023

Event Type  Injury  

Event Description

As reported, the 77 year old female patient presented with posterior dislocation of the humerus, and pain.The surgeon opened the joint to find frank pus.The patient was revised on (b)(6) 2023; all components were removed and a spacer placed in-situ.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

Pending investigation.D10: (b)(4): 315-35-00 - glnd kwire.(b)(4): 320-01-38 - equinoxe reverse 38mm glenosphere.(b)(4): 320-10-00 - equinoxe reverse tray adapter plate tray +0.(b)(4): 320-15-01 - eq rev glenoid plate.(b)(4): 320-15-05 - eq rev locking screw.(b)(4): 320-20-00 - eq reverse torque defining screw kit.(b)(4): 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm.(b)(4): 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm.(b)(4): 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm.(b)(4): 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm.(b)(4): 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm.(b)(4): 320-38-00 - equinoxe reverse 38mm humeral liner +0.(b)(4): 321-20-00 - equinoxe reverse shoulder drill kit.

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 dislocation, infection and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.

• Brand Name: EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 9MM
• 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: 16740126
• MDR Text Key: 313300475
• Report Number: 1038671-2023-00687
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10885862079305
• UDI-Public: 10885862079305
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K042021
• 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: 300-01-09
• Device Catalogue Number: 300-01-09
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/23/2023
• Initial Date Manufacturer Received: 03/23/2023
• Initial Date FDA Received: 04/13/2023
• 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: 10/23/2020
• 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: 78 YR
• Patient Sex: Female