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 07/30/2019

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 participating in a football 7-on-7 passing league for about an hour before the injury occurred.He began running straight down the field (turf), only took 2-3 steps, and felt like he hyperextended his knee.He immediately sat down and was then carried off the field.He did not participate after the injury.On (b)(6) 2019, the patient saw a physician who ordered magnetic resonance imaging (mri) which later revealed that he had torn his anterior cruciate ligament (acl), medial collateral ligament (mcl), posterior cruciate ligament (pcl), and meniscus.On (b)(6), the patient had surgery on his left knee to repair the tears.No further information has been provided.

• Brand Name: DONJOY DEFIANCE III
• Type of Device: JOINT, KNEE, EXTERNAL BRACE
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081 9663
• Manufacturer (Section G): DJO, LLC; 3151 scott st.; vista CA 92081 9663
• Manufacturer Contact: brian becker ; 2900 lake vista drive; lewisville, TX 75067
• MDR Report Key: 8962264
• MDR Text Key: 156745998
• Report Number: 3012446970-2019-00027
• 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
• Report Date: 09/04/2019

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 III
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/08/2019
• Initial Date FDA Received: 09/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2019
• 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): Required Intervention