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

Catalog Number 320-01-38

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 06/20/2023

Event Type  Injury  

Event Description

As reported, approximately 4 years post op initial left tka, this 88 y/o female patient was revised due to dislocation.Glenosphere and liner were exchanged to expanded 38mm glenosphere and +2.5 constrained liner.Patient was last known to be in stable condition following the event.Device is not returning - disposed at the hospital.

Manufacturer Narrative

Section h10: (h3) pending evaluation (d10) concomitant device(s): eq rev glenoid plate, 320-15-01 ,6234160.Eq rev compress screw lck cap kit, 4.5 x 30mm, 320-20-30, 6241389.Eq rev locking screw 320-15-05 6217896 eq rev compress screw lck cap kit, 4.5 x 34mm, 320-20-34 6239591.Equinoxe, humeral long stem 8mm 175mm ,306-01-08 ,3786648.Equinoxe reverse tray adapter plate tray +0, 320-10-00 ,6257804.Eq reverse torque defining screw kit, 320-20-00, 6237635.Equinoxe reverse 38mm humeral liner +0, 320-38-00, 6218754.

Manufacturer Narrative

Section h10: (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 and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition and the result of loosened supporting ligaments and muscles, which allowed for dislocation occurring due to the significant ligament re-construction.

Manufacturer Narrative

Section h10: (g2) report source - company representative should have been checked (g4) date received by manufacturer ¿ date on final submission should have been (16-dec-2023 (g6) type of report - 30-day should have been checked along with follow-up.

• Brand Name: EQUINOXE REVERSE 38MM GLENOSPHERE
• 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: 17640866
• MDR Text Key: 322149681
• Report Number: 1038671-2023-02069
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086389
• UDI-Public: 10885862086389
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 320-01-38
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2019
• 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: 88 YR
• Patient Sex: Female