MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE HUMERAL ADAPTER TRAY

Catalog Number 320-10-00

Device Problems Appropriate Term/Code Not Available (3191); Migration (4003)

Patient Problems Pain (1994); Joint Disorder (2373)

Event Date 07/12/2017

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

Revision due to pain and poly wear.

Manufacturer Narrative

The complaint products were received for analysis.The reported event of humeral disassociation was confirmed during analysis.Visual evaluation condition/findings (conducted with a 7x or 10x optical unless otherwise specified): the scratches on the superior surface of the adapter tray appear consistent with a combination of using a metal tool to remove the components during the revision surgery and pitting, which occurs when foreign particles, such as bone or cement fragments, get trapped between two surfaces.The scratches on the inferior surface appear consistent with contacting a hard surface while implanted.The burnished edge noted, was likely the result of the adapter tray articulating against the underside of the humeral liner after the liner disassociated from the tray.The scratches and pitting noted on the articulation surface of the liner and deformed edges appear consistent with third body wear from foreign particles, such as bone or cement fragments, getting trapped between the liner and glenosphere.The deformation and wear around the edges of the humeral liner, also noted appears consistent with contacting the glenosphere after disassociating from the adapter plate.The wear and deformation on the underside of the humeral liner appear consistent with articulating with the adapter tray following the disassociation.The discoloration noted also appears consistent with retained biological remnants from being implanted.The locking button is eccentrically deformed.This could indicate that the liner was not fully seated at the time of initial surgery.The torque defining screw appears unremarkable and consistent with successfully securing the humeral adapter tray to the humeral stem.The glenosphere appears to be contacting the medial point of the humeral tray in the follow-up x-ray, following the liner disassociation.The frequency of occurrence ranking is very low; therefore, this does not appear to be a design issue.The company is not aware of receiving any other complaint reports involving parts from these manufacturing lots.A review of the device history record showed that the humeral liner was accepted with conformance to the device requirements.Therefore, this does not appear to be manufacturing-related.The revision due to humeral liner disassociation reported in experience c2018-149 was likely the result of the humeral liner not being fully seated at the time of initial surgery, causing the humeral liner to disassociate from the adapter tray, which led to glenosphere-tray articulation.There is no patient medical information provided; therefore, it is not possible to assess the patient risk/clinical factors.In a review of the labeling it is a known complication of total joint replacements and known surgical risk that a patient may experience intractable pain and/or soft tissue damage which may lead to a second surgical intervention or revision.Device specific risks include excessive wear of the implant components secondary to impingement of components or damage of articular surfaces.The patient should be cautioned to monitor activities and protect the replaced joint from unreasonable stresses and follow the written instructions of the physician with respect to follow-up care and treatment.The patient should be cautioned to monitor activities and protect the replaced joint from unreasonable stresses and follow the written instructions of the physician with respect to follow-up care and treatment.This device is used for treatment not diagnosis.Information was requested about the event and the patient.No new information was provided.

Event Description

No additional information provided.This is one of three products involved with the reported event and the associated manufacturer report numbers are 1038671-2017-00496, and 1038671-2017-00498.

• Brand Name: EQUINOXE REVERSE HUMERAL ADAPTER TRAY
• Type of Device: HUMERAL ADAPTER TRAY
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th court; gainesville 32653
• MDR Report Key: 6735268
• MDR Text Key: 80758256
• Report Number: 1038671-2017-00497
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: K063569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/22/2019

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?: No
• Device Operator: Physician
• Device Catalogue Number: 320-10-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2017
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/18/2017
• Initial Date FDA Received: 07/24/2017
• Supplement Dates Manufacturer Received: 05/22/2019
• Supplement Dates FDA Received: 05/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention