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 Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Failure of Implant (1924)

Event Date 10/26/2018

Event Type  Injury  

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)).Additional information, including the product investigation, will be submitted within 30 days of receipt.

Event Description

As reported by the equinoxe shoulder study, approximately six years post initial right side tsa, the 64 y/o male patient experienced disassociation of humeral plate.Patient had tray dissociate with poly coming out and glenosphere loose.Patient had a revision and the event was resolved.

Manufacturer Narrative

After further review of additional information received the following sections g3, g6, h2, h3 and h6 have been updated accordingly.(h3 the revision reported was likely the result of both humeral tray disassociation, which likely led to humeral liner disassociation, and glenosphere loosening.The humeral tray disassociation may have been the result of incomplete seating/cross-threading of the reverse torque defining screw with the humeral stem and/or an unreported post traumatic event, which allowed the torque defining screw to back out and result in the reported disassociation of the humeral tray from the humeral stem.The glenosphere loosening may have been the result of the glenosphere articulating on the humeral stem after the humeral tray disassociation occurred, incomplete seating of the glenosphere locking screw and/or the glenosphere on the baseplate at the time of implantation, or a combination of these possibilities.However, these allegations 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 associated with the unwanted disassembly of the device, or incorrect assembly of the device (attaching mating instrumentation incorrectly, assembling an implant construct off-axis, etc.).

• 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: 16130863
• MDR Text Key: 307001531
• Report Number: 1038671-2023-00031
• 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: 07/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/29/2013
• 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
• Initial Date Manufacturer Received: 12/22/2022
• Initial Date FDA Received: 01/10/2023
• Supplement Dates Manufacturer Received: 06/22/2023
• Supplement Dates FDA Received: 07/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2008
• 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: 64 YR
• Patient Sex: Male
• Patient Weight: 120 KG
• Patient Race: White