MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 7MM; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 7MM

Device Problem Fracture (1260)

Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924)

Event Date 09/15/2022

Event Type  Injury  

Manufacturer Narrative

Additional information, including the product investigation, will be submitted within 30 days of receipt.

Event Description

As reported, female patient had a periprosthetic fracture of the stem.Patient was revised to hrp.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.X-rays and photos received.The device is not available for evaluation due to hospital policy.

Manufacturer Narrative

Section b5: additional information received indicates that patient's bone was broken on distal part of the stem.Section d10: concomitant products: equinoxe reverse 38mm glenosphere (cat#: 320-01-38 / serial#: (b)(6).Equinoxe reverse tray adapter plate tray +0 (cat#: 320-10-00 / serial#: (b)(6).Eq rev glenoid plate (cat#: 320-15-01 / serial#: (b)(6).Eq rev locking screw (cat#: 320-15-05 / serial#: (b)(6).Eq reverse torque defining screw kit (cat#: 320-20-00 / serial#: (b)(6).Eq rev compress screw lck cap kit, 4.5 x 22mm (cat#: 320-20-22 / serial#: (b)(6).Eq rev compress screw lck cap kit, 4.5 x 22mm (cat#: 320-20-22 / serial#: (b)(6).Eq rev compress screw lck cap kit, 4.5 x 26mm (cat#: 320-20-26 / serial#: (b)(6).Eq rev compress screw lck cap kit, 4.5 x 30mm (cat#: 320-20-30 / serial#: (b)(6).145-deg pe 38mm hum liner +0 (cat#: 320-38-00 / serial#: (b)(6).(h3) as reported, female patient had a periprosthetic fracture of the stem.Patient was revised to hrp.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.X-rays and photos received.The device is not available for evaluation due to hospital policy.Upon review of the available information, there is no evidence that this is a device related problem and there is no allegation against the device.Implantation of a total joint could result pain, infection, or loosening of total joint hardware.The most likely cause of the reported event was a malunion of a fracture which was likely caused by over-reaming during implantation.

• Brand Name: EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 7MM
• 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 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15720381
• MDR Text Key: 302946110
• Report Number: 1038671-2022-01373
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862079299
• UDI-Public: 10885862079299
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042021
• 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: 05/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2019
• Device Model Number: EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 7MM
• Device Catalogue Number: 300-01-07
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2009
• 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 Sex: Female