MAUDE Adverse Event Report: EXACTECH, INC. HUMERAL STEM

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Material Split, Cut or Torn (4008)

Patient Problems Joint Disorder (2373); No Information (3190)

Event Date 04/16/2008

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

Index surgery: (b)(6) 2005.Revision due to rotator cuff tear confirmed by ct scan (b)(6) 2008.

Manufacturer Narrative

Engineering evaluation noted that the revision reported was likely the result of a rotator cuff tear.However, this cannot be confirmed as the devices were not available for evaluation and no further information was provided.

Event Description

Index surgery: (b)(6) 2005.Revision due to rotator cuff tear confirmed by ct scan (b)(6) 2008.

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.Rotator cuff strains or tears are caused by overuse with activity 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 rotator cuff and the subsequent revision, it is most likely related to the patient's underlying conditions.This device is used for treatment, not diagnosis.

Event Description

This is one of four products involved with the reported event and the associated manufacturer report numbers are 1038671-2018-0614, 1038671-2018-00615 and 1038671-2018-00616.

• Brand Name: HUMERAL STEM
• Type of Device: HUMERAL STEM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• MDR Report Key: 7703191
• MDR Text Key: 114458173
• Report Number: 1038671-2018-00613
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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: 53 YR