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

Catalog Number 320-42-00

Device Problems Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 12/21/2017

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

Index surgery: (b)(6) 2017.Revision due to instability.

Manufacturer Narrative

After further review of additional information received the following sections date of report, event, relevant tests/laboratory data, other relevant history, expiration date, initial reporter occupation, pma/510k, if follow-up, what type, device manufacture date and adverse event problem have been updated accordingly.In a review of the labeling it is a known complication that a patient's age, weight, or activity level would cause the surgeon to expect early failure of the system.Device specific risks that fracture, migration, loosening, subluxation, or dislocation of the prothesis or any of its components, any of which may require a second surgical intervention or revision.Revisions or surgical interventions are a known complication found in joint replacements.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of patient instability of the shoulder joint devices is most likely due to the patient's underlying conditions.This device is used for treatment, not diagnosis.No device evaluation pending.

Event Description

It was reported that patient experienced a revision surgery of shoulder devices due to instability.The patient was having an "unstable" shoulder joint device and the surgeon determined to put the reverse in with more tension, thus upsized the humeral implants by 5mm.The liner and adapter tray were removed using appropriate devices, a trial was done using a plus 5mm adapter tray insert and 0mm liner to mate with the 42mm glenosphere.The surgeon felt comfortable with the upsize.The patient surgical outcome was noted to be successful.There is no indication or complaint that the device malfunctioned.No additional information has been provided.This is one of three products involved with the reported event and the associated manufacturer report numbers are 1038671-2017-00934 and 1038671-2017-00935.

• Brand Name: EQUINOXE REVERSE HUMERAL LINER
• Type of Device: EQUINOXE REVERSE HUMERAL LINER
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• MDR Report Key: 7147844
• MDR Text Key: 95823556
• Report Number: 1038671-2017-00936
• 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
• Report Date: 01/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 11/22/2021
• Device Catalogue Number: 320-42-00
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR