MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE HUMERAL HEAD, SHORT

Catalog Number 310-01-41

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Bone Fracture(s) (1870); Joint Disorder (2373)

Event Date 05/19/2017

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

Previous surgery: (b)(6) 2016.Revision of left shoulder components due to subscapularis tear.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.The cause of the subscapularis rotator cuff tear is most likely related to the patient's underlying conditions of age, degenerative joint disease and previous shoulder maladies.This device is used for treatment, not diagnosis.

Event Description

No addition information provided.This is one of five products involved with the reported event and the associated manufacturer report numbers are 1038671-2018-00323, 1038671-2018-00324, 1038671-2018-00325, 1038671-2018-00327.

• Brand Name: EQUINOXE HUMERAL HEAD, SHORT
• Type of Device: HUMERAL HEAD
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th ct; gainesville FL 32653
• MDR Report Key: 6612273
• MDR Text Key: 76673293
• Report Number: 1038671-2017-00326
• Device Sequence Number: 1
• Product Code: HSD
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 01/07/2019

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: 310-01-41
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/19/2017
• Initial Date FDA Received: 06/05/2017
• Supplement Dates Manufacturer Received: 01/07/2019
• Supplement Dates FDA Received: 01/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Weight: 65