MAUDE Adverse Event Report: EXACTECH, INC EQUINOXE PLATFORM FRACTURE STEM, LEFT

Catalog Number 304-21-09

Device Problems Unexpected Therapeutic Results (1631); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Osteolysis (2377); Impaired Healing (2378)

Event Date 09/23/2016

Event Type  Injury  

Manufacturer Narrative

The contribution of the devices 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) 2016.Reoperation to excise tuberosities due to tuberosity resorption.This event report was received through clinical data collection activities.

Event Description

Operation was to the left shoulder.The patient had a follow up (b)(6) 2017 and has had no further complications or complaints.This is one of two products involved with the reported event and the associated manufacturer report numbers are 1038671-2017-00112, 1038671-2017-00113, 1038671-2017-00114, 1038671-2017-00115 and 1038671-2017-00116.

Manufacturer Narrative

It is known complication that revision surgeries occur.Also, as part of the pre-operative assessment, the surgeon must ensure that no biological, biomechanical, or other factors exist that might adversely affect the surgery and/or the postoperative period.There is no indication that there is a device related problem/malfunction, there is no allegation against any device.The most likely cause of the reported event is related to the underlying conditions of the patient.This device is used for treatment not diagnosis.

• Brand Name: EQUINOXE PLATFORM FRACTURE STEM, LEFT
• Type of Device: STEM
• Manufacturer (Section D): EXACTECH, INC; 2320 nw 66th ct; gainesville FL 32653
• MDR Report Key: 6368627
• MDR Text Key: 68747211
• Report Number: 1038671-2017-00111
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• PMA/PMN Number: K092900
• 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: 12/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 304-21-09
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR
• Patient Weight: 72