MAUDE Adverse Event Report: DJO, LLC DONJOY DEFIANCE FP; JOINT, KNEE, EXTERNAL BRACE

Model Number CONV DEFIANCE FP

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Damage to Ligament(s) (1952)

Event Date 05/13/2019

Event Type  Injury  

Manufacturer Narrative

Device evaluated by mfr: no device was returned for evaluation.If the device is received, a follow-up report will be submitted upon completion of product evaluation.

Event Description

It was reported that the patient had hurt his knee again and was having surgery.According to the patient, he was about to ride his dirt bike for the first time of the year.After he put all his gear on, including the knee brace, he hopped out of the back of his truck and his "knee blew out".He did not go to a doctor right away, hoping that it was just a sprain.Then it happened again, so he went to see his doctor, who ordered magnetic resonance imaging (mri).Surgery to repair his anterior cruciate ligament was scheduled for may 23rd.

Manufacturer Narrative

H3, h6: device was returned for evaluation.During device evaluation results were observed to be within device specifications.Device performed as expected.Could not duplicate reported event.No failure identified.

• Brand Name: DONJOY DEFIANCE FP
• Type of Device: JOINT, KNEE, EXTERNAL BRACE
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081 9663
• MDR Report Key: 8796055
• MDR Text Key: 151224679
• Report Number: 3012446970-2019-00022
• Device Sequence Number: 1
• Product Code: ITQ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 09/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: CONV DEFIANCE FP
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/13/2019
• Initial Date FDA Received: 07/16/2019
• Supplement Dates Manufacturer Received: 05/13/2019
• Supplement Dates FDA Received: 09/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention