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 02/17/2020

Event Type  Injury  

Manufacturer Narrative

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 was "practicing with her school team while wearing her brace, [patient] planted her left leg and turned to shoot and went down screaming.She did not hear a pop this time but the pain was worse then the first time.[sic] [patient] saw an orthopedist the day after her injury, (b)(6) 2020.They did an x-ray at that time which didn't show anything.They followed up with an mri [magnetic resonance imaging] on thursday (b)(6) 2020.The following monday we saw the same orthopedic surgeon that preformed the first surgery and he confirmed the results of the mri showed a re-tear of the acl [anterior cruciate ligament] in her left knee and it was decided she needed another surgery.Her new surgery is scheduled for (b)(6) 2020." no further information is currently available.

Manufacturer Narrative

G1,2: updated manufacturer point of contact information.H3, h6: device was returned for product evaluation.During this evalution the device was found to be both in good condition and functional.Per the condition, functionality, and manufacturing forms - the device was found to be built within device specifications and no issues were identified.

• Brand Name: DONJOY DEFIANCE FP
• Type of Device: JOINT, KNEE, EXTERNAL BRACE
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista, ca
• MDR Report Key: 9864810
• MDR Text Key: 196476424
• Report Number: 3012446970-2020-00011
• 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: 07/06/2020

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: 03/12/2020
• Initial Date FDA Received: 03/23/2020
• Supplement Dates Manufacturer Received: 03/12/2020
• Supplement Dates FDA Received: 07/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention