MAUDE Adverse Event Report: EXACTECH, INC. HUMERAL TRAY

Device Problems Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Joint Disorder (2373); No Code Available (3191)

Event Date 03/16/2018

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

Index surgery: (b)(6) 2014.Revision due to dislocation.This event report was received through clinical data collection activities.

Event Description

It was reported that the dislocation was accompanied by pain and functional impairment which reappeared after the patient slept on the right shoulder.Muscle retraction which prevented the (closed) reduction of the subluxation.There is no sign of loosening and no sign of inflammation.No additional information provided.This is one of five products involved with the reported event and the associated manufacturer report numbers are 1038671-2018-00486, 1038671-2018-00487, and 1038671-2018-00488.

Manufacturer Narrative

After further review of additional information received the following sections a2 in a review of the labeling it is a known complication that a patient's age, weight, trauma, or activity level would cause the surgeon to expect early failure of the system.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 dislocation of the right shoulder joint devices is most likely related to the trauma of "sleeping on the shoulder" and the patient's underlying conditions to include previous shoulder maladies.This device is used for treatment, not diagnosis.

• Brand Name: HUMERAL TRAY
• Type of Device: HUMERAL TRAY
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• MDR Report Key: 7569758
• MDR Text Key: 110095158
• Report Number: 1038671-2018-00485
• 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
• Report Date: 01/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2018
• 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: 01/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Weight: 95