MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +5

Catalog Number 320-10-05

Device Problem Unstable (1667)

Patient Problem Failure of Implant (1924)

Event Date 09/11/2018

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.Concomitant medical products: torque defining screw kit (cat# 320-20-00 / sn# (b)(4)), 42mm humeral liner +0 (cat# 320-42-00 / sn# (b)(4)).

Event Description

As reported, approximately 8 years and 3 months post right shoulder implant, the patient had a revision hrp.This case was the second revision for this patient.The patient presented with instability with her shoulder and the physician chose to revise her hrp with a constrained liner.The physician began by gaining exposure to the joint space.He dislocated the shoulder.He removed the humeral liner, and humeral adapter tray.He then trailed the intended sizes of implants.He deemed those sizes appropriate and implanted the humeral tray with the torque screw and then impacted the poly liner insitu.The patient was closed in the usual fashion, left the or stable, and was expected to have a good outcome.There was no delay to the surgery.There was no reported patient injury.The devices will not be returned for evaluation.No further information available at this time.

Manufacturer Narrative

Section h10: (g5) pma/510(k)number: k063569.(h3) approximately 8 years and 3 months post right shoulder implant, the patient had a revision hrp.This case was the second revision for this patient.The patient presented with instability with her shoulder.Upon review of the available information, there is no evidence that this is a device related problem and no allegation against the device.Implantation of a total joint could result pain, infection, loosening of total joint hardware or fracture.The fracture is now fully healed.The most likely cause of the reported event is the patient¿s underlying condition.(h4) manufacture date: 24-feb-2029.

• Brand Name: EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +5
• Type of Device: EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +5
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 8946826
• MDR Text Key: 160735260
• Report Number: 1038671-2019-00429
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086426
• UDI-Public: 10885862086426
• Combination Product (y/n): N
• PMA/PMN Number: K063569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 11/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 320-10-05
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention