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

Catalog Number 320-10-00

Device Problems Failure To Adhere Or Bond (1031); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 02/09/2017

Event Type  Injury  

Manufacturer Narrative

The contribution of the device to the experience reported could not be determined as the device was not returned for evaluation.Additionally, the device specific information was not provided, precluding a review of the device history record.

Event Description

Index surgery: (b)(6) 2012.Revision of right shoulder components due to aseptic humeral loosening.This event report was received through clinical data collection activities.

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.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 most likely cause of surgical revision to the right shoulder joint devices is most likely due to the patient's underlying conditions, including age and other shoulder maladies.This device is used for treatment, not diagnosis.No information has been provided.Information not provided (as needed).

Event Description

This is one of five products involved with the reported event and the associated manufacturer report numbers are 1038671-2017-00187, 1038671-2017-00189, 1038671-2017-00190 and 1038671-2017-00191.

• Brand Name: EQUINOXE REVERSE HUMERAL ADAPTER TRAY
• Type of Device: HUMERAL ADAPTER TRAY
• Manufacturer (Section D): EXACTECH, INC; 2320 nw 66th ct; gainesville FL 32653
• MDR Report Key: 6420185
• MDR Text Key: 70413517
• Report Number: 1038671-2017-00188
• 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,study
• Type of Report: Initial,Followup
• Report Date: 03/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2017
• 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?: No
• Date Manufacturer Received: 03/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Weight: 49