MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE 38MM HUMERAL LINER +0; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number 320-38-00

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 10/17/2022

Event Type  Injury  

Event Description

As reported, approximately 5 months post op the initial right tsa, this 73 y/o male patient was revised due to dislocation.The surgeon decided to change the liner to a +2.5mm and replace the adaptor plate.There were no reported issues with the revision surgical procedure.The patient was last known to be in stable condition following the event.No other patient information/medical history provided.The device will not be returned; disposed of by hospital.

Manufacturer Narrative

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 shoulder dislocation and revision cannot be conclusively determined; however, it is most likely patient related conditions.Concomitant medical products: (b)(4), 321-20-00, equinoxe reverse shoulder drill kit.(b)(4), 320-15-05, eq rev locking screw.(b)(4), 320-20-00, eq reverse torque defining screw kit.(b)(4), 320-10-00, equinoxe reverse tray adapter plate tray +0.(b)(4), 300-01-13, equinoxe, humeral stem primary, press fit 13mm.(b)(4), 320-01-38, equinoxe reverse 38mm glenosphere.(b)(4), 320-15-01, eq rev glenoid plate.(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.

• Brand Name: EQUINOXE REVERSE 38MM HUMERAL LINER +0
• 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 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 15707514
• MDR Text Key: 302770203
• Report Number: 1038671-2022-01379
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086655
• UDI-Public: 10885862086655
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K063569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 320-38-00
• Device Catalogue Number: 320-38-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2022
• Date Device Manufactured: 01/28/2021
• 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 Age: 73 YR
• Patient Sex: Male