MAUDE Adverse Event Report: DJO, LLC DONJOY; DEFIANCE III FP

Model Number DEFIANCE III FP

Device Problems Component Missing (2306); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Damage to Ligament(s) (1952)

Event Date 09/15/2016

Event Type  Injury  

Manufacturer Narrative

Not returned.

Event Description

Complaint received that alleges "he was running when the brace broke with caused him to fall.As a result he tore his acl and a ligament in his hip as well".Questionnaire not received from customer or clinician.Device not returned to manufacturer for evaluation.

• Brand Name: DONJOY
• Type of Device: DEFIANCE III FP
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081 9663
• Manufacturer (Section G): DJO, LLC; 3151 scott street; vista CA 92081 9663
• Manufacturer Contact: william fisher ; 1430 decision street; vista, CA 92081 ; 7607313126
• MDR Report Key: 5993461
• MDR Text Key: 56186118
• Report Number: 2020737-2016-00013
• Device Sequence Number: 1
• Product Code: ITQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: DEFIANCE III FP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other