MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number 320-15-05

Device Problem Break (1069)

Patient Problem Pain (1994)

Event Date 01/01/2023

Event Type  Injury  

Event Description

It was reported via clinical study, that the 59 yo female patient experienced pain due to breakage of the inferior glenoid screw component.(screws, stem, etc.) the treatment action taken was an mri to assess cervical issues.The results are pending, and possible revision may be needed.The date of onset is (b)(6) 2023.The patient¿s outcome was last known as continuing.

Manufacturer Narrative

Concomitants medical products: serial #: (b)(4), category #: 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm, serial #: (b)(4), category #: 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm.Serial #: (b)(4), category #: 320-01-38 - equinoxe reverse 38mm glenosphere.Serial #: (b)(4), category #: 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm.Serial #: (b)(4), category #: 320-10-00 - equinoxe reverse tray adapter plate tray +0.Serial #: (b)(4), category #: 320-38-03 - equinoxe reverse 38mm humeral liner +2.5.Serial #: (b)(4), category #: 320-15-01 - eq rev glenoid plate.Serial #: (b)(4), category #: 320-20-00 - eq reverse torque defining screw kit.Serial #: (b)(4), category #: 300-30-06 - equinoxe preserve stem 6mm.

• Brand Name: EQUINOXE
• 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 66th ct.; gainesville FL 32563
• Manufacturer Contact: kate jacobson
• MDR Report Key: 16553777
• MDR Text Key: 311404825
• Report Number: 1038671-2023-00449
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086495
• UDI-Public: 10885862086495
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 320-15-05
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/07/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 102 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White