MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE 42MM HUMERAL LINER +2.5; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number 320-42-03

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Failure of Implant (1924)

Event Date 07/25/2023

Event Type  Injury  

Manufacturer Narrative

Section h10: (h3) pending evaluation: (d10) concomitant device(s): humeral adaptor tray +0mm 320-10-00 5900857.Glenosphere 42mm 320-01-42 6154427.Humeral liner 42mm, +2.5mm 320-42-03 4483543.Glenosphere locking screw 320-15-05 6113795.Reverse shoulder torque defining screw 320-20-00 6115379.Rs glenoid plate sup aug, 10 deg 320-15-02 5958989.Equinoxe preserve stem 11mm 300-30-11 5729693.Eq rev compress screw lck cap kit, 4.5 x 38mm 320-20-38 5930239.Eq rev compress screw lck cap kit, 4.5 x 38mm 320-20-38 6113880.Eq rev compress screw lck cap kit, 4.5 x 26mm 320-20-26 6015034.Eq rev compress screw lck cap kit, 4.5 x 42mm 320-20-42 6058870.

Event Description

As reported, approximately 4 years post op initial right tsa, this 71 y/o male patient was revised due to humeral liner dissociation.Humeral liner was dissociated from the humeral tray.Glenosphere, liner and tray were revised.Patient was last known to be in stable condition following the event.No other patient information/medical history reported.Photo attached.Unable to obtain x-rays.Product not returning - disposed by hospital.

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 (b)(6) 2023 (g6) type of report - 30-day should have been checked along with follow-up.

Manufacturer Narrative

Section h10: h3) the revision reported was likely the result of incomplete seating of the liner during implantation, bone impingement, patient-related conditions, an unreported post-traumatic event, or any combination of these possibilities, which led to humeral liner disassociation.However, this cannot be confirmed as the devices were not returned for evaluation and radiographs were not provided.

• Brand Name: EQUINOXE REVERSE 42MM HUMERAL LINER +2.5
• 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: 17642845
• MDR Text Key: 322186517
• Report Number: 1038671-2023-02076
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086709
• UDI-Public: 10885862086709
• Combination Product (y/n): N
• Reporter Country Code: NZ
• 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 Expiration Date: 07/05/2021
• Device Catalogue Number: 320-42-03
• 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: 07/07/2016
• 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 Age: 71 YR
• Patient Sex: Male