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

Model Number CONV DEFIANCE III

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

Patient Problem Damage to Ligament(s) (1952)

Event Date 01/10/2020

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 "lost my balance and did one or two cartwheels and pop.I'm guessing my knee was hyperextended as i was cartwheeling and as the ski popped off so did my acl (anterior cruciate ligament).I waited a couple minutes to let the pain subside but the second i tried to click back into my ski i knew the acl was gone.I skied down on my left ski to the door of the first aid clinic at the base of the resort." no further information is currently available.

Manufacturer Narrative

H3, h6: one conv defiance iii brace, serial number (b)(6) , was returned for evaluation.Brace paint and soft goods have some wear/tear from use.Brace is functional.Per the condition, functionality, and manufacturing form; the brace is built within specifications.No issues were found.

• Brand Name: DONJOY DEFIANCE III
• Type of Device: JOINT, KNEE, EXTERNAL BRACE
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista, ca
• MDR Report Key: 9694714
• MDR Text Key: 182180357
• Report Number: 3012446970-2020-00004
• 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: 02/16/2020

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: Health Professional
• Device Model Number: CONV DEFIANCE III
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2020
• Initial Date Manufacturer Received: 01/28/2020
• Initial Date FDA Received: 02/11/2020
• Supplement Dates Manufacturer Received: 01/28/2020
• Supplement Dates FDA Received: 02/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention