MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE HUMERAL STEM, PRIMARY, PRESS-FIT

Catalog Number 300-01-09

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Pain (1994); Loss of Range of Motion (2032)

Event Date 03/31/2016

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.Pending evaluation.

Event Description

Index surgery: (b)(6) 2015.Revision of left shoulder components due to patient having the inability to raise arm and pain.Possible tear.This event report was received through clinical data collection activities.

Manufacturer Narrative

The most common causes of rotator cuff injury are due to acute injury or degenerative injuries (repeated over use) that can commonly occur to people over 40 years of age.There is no indication that there was a malfunction with the device, the most likely cause of the rotator cuff injury is related to patient condition.The device is intended for individuals who have degenerative disease of the shoulder.Indications for use: the shoulder system is indicated for use in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral joint where total or hemi- arthroplasty is determined by the surgeon to be the preferred method of treatment.All patients should be instructed on the limitations of the prosthesis and the possibility of subsequent surgery.The patient should be cautioned to monitor activities and protect the replaced joint from unreasonable stresses and follow the written instructions of the physician with respect to follow-up care and treatment.The patient should be warned against unassisted activity, particularly in lifting, and that active motion should not be initiated until recommended by the surgeon in order to ensure subscapularis healing is complete.Normal wear of the implant given the state of knowledge at the time of its design cannot in any way be considered to constitute a dysfunction or deterioration in the characteristics of the implant.

Event Description

It was reported and is noted that the patient had a postero-sup rotator cuff tear.Revision surgery was conducted on (b)(6) 2016 with the outcome noted as resolved.No additional information provided.Associated mfrs for this event: 1038671-2017-00381, 1038671-2017-00382, 1038671-2017-00383, 1038671-2017-00384, and 1038671-2017-00385.

• Brand Name: EQUINOXE HUMERAL STEM, PRIMARY, PRESS-FIT
• Type of Device: HUMERAL STEM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: graham cuthbert ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 6644051
• MDR Text Key: 77650908
• Report Number: 1038671-2017-00381
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/09/2018

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: Health Professional
• Device Catalogue Number: 300-01-09
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/05/2017
• Initial Date FDA Received: 06/15/2017
• Supplement Dates Manufacturer Received: 11/08/2018
• Supplement Dates FDA Received: 11/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Weight: 89