MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE 38MM HUMERAL CONST LINER +2

Catalog Number 320-38-13

Device Problems Device Dislodged or Dislocated (2923); Insufficient Information (3190)

Patient Problems Failure of Implant (1924); Joint Disorder (2373)

Event Date 09/26/2018

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

Revision due to dislocation.

Event Description

It was reported that a patient had a shoulder revision due to dislocation.No additional information has been provided on the patient or event.

Manufacturer Narrative

In a review of the labeling it is a known complication that a patient's age, weight, activity level, and/or trauma would cause the surgeon to expect early failure of the system.That there are device specific risks of fracture, migration, loosening, subluxation, or dislocation of the prothesis or any of its components, and any of which may require a second surgical intervention or revision.As part of the preoperative assessment, the surgeon must ensure that no biological, biomechanical, or other factors exist that might adversely affect the surgery and/or postoperative period.Revisions or surgical interventions are a known complication found in joint replacements.There is no patient information provided, therefore, it is not possible to make a patient risk/clinical assessment.This device is used for treatment, not diagnosis section(s): no information has been provided.Corrected data: device evaluated by manufacturer - yes- it was reported in follow-up #1.

Event Description

Revision due to disloction.

Manufacturer Narrative

The revision reported was likely the result of loosened supporting ligaments, which led to dislocation.However, this cannot be confirmed as the devices were not available for evaluation, and no further information was provided.

• Brand Name: EQUINOXE REVERSE 38MM HUMERAL CONST LINER +2
• Type of Device: LINER
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• MDR Report Key: 7914778
• MDR Text Key: 121897341
• Report Number: 1038671-2018-00798
• 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: 04/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 320-38-13
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Weight: 92