MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Failure of Implant (1924)

Event Date 01/30/2024

Event Type  Injury  

Manufacturer Narrative

Section d10: concomitant products equinoxe reverse 42mm humeral liner +0 (cat# 320-42-00 / serial# (b)(6)) equinoxe reverse tray adapter plate tray +0 (cat# 320-10-00 / serial# (b)(6)) eq reverse torque defining screw kit (cat# 320-20-00 / serial# (b)(6)) additional information, including the product investigation, will be submitted within 30 days of receipt.

Event Description

As reported, approximately three months post initial right tsa, the 58 y/o male patient presented with recurring dislocation due to undersized/loose stem.Patient had a replacement of stem, liner, glenosphere, torque screw, and locking screw.There was no reported breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Sales rep was unable to obtain images or x-rays.The devices are not available for evaluation due to they were disposed by hospital.No further information provided.

• Brand Name: EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM
• 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: miguel soza
• MDR Report Key: 18763871
• MDR Text Key: 336055269
• Report Number: 1038671-2024-00312
• Device Sequence Number: 1
• Product Code: KWT
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM
• Device Catalogue Number: 300-01-11
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/31/2023
• 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: EQ REV COMPRESS SCREW LCK CAP KIT; EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 18MM; EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM; EQ REV GLENOID PLATE; EQ REV LOCKING SCREW; EQUINOXE REVERSE 42MM GLENOSPHERE
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male