MAUDE Adverse Event Report: EXACTECH, INC. HUMERAL LINER

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 03/14/2018

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

Index surgery: (b)(6) 2017.Revision due to pain.This event report was received through clinical data collection activities.

Manufacturer Narrative

Engineering evaluation noted that the revision reported was likely the result of pain.However, this cannot be confirmed as the device was not available for evaluation and no further information regarding the event was provided.

Event Description

Index surgery: (b)(6) 2017.Revision due to pain.This event report was received through clinical data collection activities.

• Brand Name: HUMERAL LINER
• Type of Device: HUMERAL LINER
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: graham cuthbert ; 2320 nw 66th court; gainesville, FL 32653
• MDR Report Key: 7792796
• MDR Text Key: 117444489
• Report Number: 1038671-2018-00687
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2018
• 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: 08/16/2018
• 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: 79 YR
• Patient Weight: 69