MAUDE Adverse Event Report: EXACTECH, INC. HUMERAL HEAD

Device Problems Loose or Intermittent Connection (1371); Adverse Event Without Identified Device or Use Problem (2993); Torn Material (3024)

Patient Problems Joint Disorder (2373); No Known Impact Or Consequence To Patient (2692)

Event Date 01/30/2018

Event Type  Injury  

Manufacturer Narrative

This event report was received through clinical data collection activities.Pending evaluation.

Event Description

Index surgery: (b)(6) 2012.Revision of shoulder components due to rotator cuff tear and glenoid loosening.The case report form indicates this event is definitely not related to devices or procedure.

Event Description

No addition information provided.This is one of five products involved with the reported event and the associated manufacturer report numbers are 1038671-2018-00450, 1038671-2018-00451, 1038671-2018-00452 and 1038671-2018-00454.

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 rotator cuff tear and glenoid loosening is most likely related to the patient's underlying conditions.This device is used for treatment, not diagnosis.

• Brand Name: HUMERAL HEAD
• Type of Device: HUMERAL HEAD
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• MDR Report Key: 7502306
• MDR Text Key: 107844410
• Report Number: 1038671-2018-00453
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• 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: 01/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 61