MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +5; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +5

Device Problems Activation, Positioning or Separation Problem (2906); Device Dislodged or Dislocated (2923)

Patient Problem Failure of Implant (1924)

Event Date 12/08/2022

Event Type  Injury  

Event Description

As reported by the equinoxe shoulder study, approximately four years post initial right side tsa, the 69 y/o patient experienced disassociation of humeral plate.Patient was sitting and reaching out with sudden pain humeral tray disassociation; this was the second occurrence of tray issue.Patient had a standard reverse procedure six days later and the standard humeral stem, torque screw, humeral tray, humeral liner, glenosphere and glenosphere locking screw were removed.

Manufacturer Narrative

Concomitant products: equinoxe reverse 42mm humeral liner +2.5 (cat# 320-42-03 / serial# (b)(4)); rs expanded glenosphere 42mm, +4mm offset (cat# 320-02-42 / serial# (b)(4)); eq rev locking screw (cat# 320-15-05 / serial# (b)(4)); eq reverse torque defining screw kit (cat# 320-20-00 / serial# (b)(4)).Additional information, including the product investigation, will be submitted within 30 days of receipt.

Manufacturer Narrative

(h3) the revision reported may have been the result of not replacing the humeral stem during the first revision due to humeral tray/torque screw disassociation, which may have led to implanting a new torque defining screw into a humeral stem with damaged threads.This deformation likely did not allow for the new torque screw to be fully seated during the first revision surgery, resulting in the torque defining screw backing out of the humeral stem and subsequently the humeral tray disassociating from the humeral stem.However, this cannot be confirmed as the devices were not returned for evaluation and images/radiographs were not provided.The most probable root cause associated with the reported event of ¿disassembled / misassembled¿ is problem associated with one device causing harm to another device.

• Brand Name: EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +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 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16130961
• MDR Text Key: 307001671
• Report Number: 1038671-2023-00030
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086426
• UDI-Public: 10885862086426
• 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,Followup
• Report Date: 06/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +5
• Device Catalogue Number: 320-10-05
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2018
• 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: 69 YR
• Patient Sex: Male
• Patient Race: White