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

Catalog Number 300-01-11

Device Problems Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Injury (2348); Joint Disorder (2373)

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) 2012.Revision of shoulder components due to subscapularis tear and instability.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, or activity level would cause the surgeon to expect early failure of the system.Postoperative rotator cuff tear is a known complication associated with total shoulder arthroplasty.Rotator cuff strains or tears are caused by overuse or acute injury.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.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 cause of the rotator cuff and anterior instability is most likely related to the patient's underlying conditions.This device is used for treatment, not diagnosis.There is no information for section(s): a5., b3., d4.Serial and expiration date and h4.Corrected data: section b5: planned revision, no information has been provided if the revision occurred or what devices were involved.Section h3: no evaluation pending.

Event Description

It was reported from the study that there was a planned revision, no information has been provided if the revision occurred or what devices were involved.The patient went to another provider.A subscapularis tear and anterior instability are reported to have an onset event date of (b)(6) 2016.The patient went to another provider.No additional information provided.This is one of four products involved with the reported event and the associated manufacturer report numbers are 1038671-2017-00387, 1038671-2017-00388 and 1038671-2017-00389.

• 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
• MDR Report Key: 6652901
• MDR Text Key: 77919397
• Report Number: 1038671-2017-00386
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: K042021
• 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: 01/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 300-01-11
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Weight: 73