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

Device Problems Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Joint Disorder (2373); No Code Available (3191)

Event Date 01/24/2018

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

Revision of equinoxe shoulder components.

Manufacturer Narrative

All patients should be instructed on the limitations of the prosthesis and the possibility of subsequent surgery.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 warned against unassisted activity, particularly in lifting, and that active motion should not be initiated until recommended by the surgeon in order to ensure subscapularis healing is complete.Normal wear of the implant given the state of knowledge at the time of its design cannot in any way be considered to constitute a dysfunction or deterioration in the characteristics of the implant.Upon review of all available information, the revision of the reverse shoulder components reported in experience (b)(4) was likely the result of either wear, loosening, infection, fracture, instability, or patient-related factors.However, this cannot be confirmed because the devices were not available for evaluation and adequate information was not provided this device is used for treatment not diagnosis.

Event Description

It was reported that on (b)(6) 2018 a patient previously implanted during a total shoulder arthroplasty was revised.The date of the initial implant is unknown and the reason for the revision was not reported.No other information was available.After reviewing information on the file, it was determined that the serial numbers reported on reports 1038671-2018-00075 and 1038671-2018-00227 were from the revision components and not the initial implants.Initial implant date is unknown at this time.This is one of three products involved with the reported event and the associated manufacturer report numbers are 1038671-2018-00075, 1038671-2018-00227.

Manufacturer Narrative

Corrected data: catalog number and serial numbers originally were incorrect.Device catalog and serial numbers are unknown at this time.This is one of three products involved with the reported event and the associated manufacturer report numbers are 1038671-2018-00075, 1038671-2018-00226 and 1038671-2018-00227.

• Brand Name: EQUINOXE REVERSE HUMERAL LINER
• Type of Device: LINER
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• MDR Report Key: 7323641
• MDR Text Key: 101868468
• Report Number: 1038671-2018-00226
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 06/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention