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

Catalog Number 320-38-00

Device Problems Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924); Fracture, Arm (2351)

Event Date 02/08/2017

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) 2014.Non-revision of right shoulder components due to a non-displaced periprosthetic humeral fracture.This event report was received through clinical data collection activities.

Event Description

The patient was seen on (b)(6) 2017, no surgical intervention, the patient is splinting and bracing the arm shoulder.Associated mfrs with this event: 1038671-2017-00117, 1038671-2017-00119, 1038671-2017-00120, 1038671-2017-00121, 1038671-2017-00122 & 1038671-2017-00124.

Manufacturer Narrative

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.The patient has a history of liver disease and hypertension which are patient conditions that could reasonably affect the patient and the reported event.There is no indication that there is a device related problem, there is no allegation against the device.The most likely cause of the reported event is related to the underlying patient condition.This device is used for treatment not diagnosis.

Manufacturer Narrative

Mfr # 1038671-2017-00124 is not associated with this event.

• Brand Name: EQUINOXE REVERSE HUMERAL LINER
• Type of Device: HUMERAL LINER
• Manufacturer (Section D): EXACTECH, INC; 2320 nw 66th ct; gainesville FL 32653
• MDR Report Key: 6372414
• MDR Text Key: 68814208
• Report Number: 1038671-2017-00118
• 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,Followup
• Report Date: 11/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 320-38-00
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/16/2017
• Initial Date FDA Received: 03/02/2017
• Supplement Dates Manufacturer Received: 11/27/2018; 11/28/2018
• Supplement Dates FDA Received: 11/27/2018; 11/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR
• Patient Weight: 73