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

Model Number CONV DEFIANCE III FP

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

Patient Problem Damage to Ligament(s) (1952)

Event Date 01/24/2020

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 playing basketball while wearing the brace, went for a loose ball, knee twisted with immediate pain.She did not hear a "pop" after going for the loose ball, she fell and was in immense pain and discomfort.She was in agony.Also, she could not bare weight on the knee afterwards.[sic] she had to be carried.The knee was very painful and unstable.She went to see an orthopedic doctor the next day.They did an x-ray.An mri (magnetic resonance imaging) was ordered/scheduled on (b)(6)2020.A follow up appointment was made.For (b)(6) 2020.Mri showed a torn acl (anterior cruciate ligament) and lateral meniscus bucket tear of the right knee.On (b)(6) 2020, an acl revision with patella graft and a lateral meniscectomy of the right knee was performed.".

• Brand Name: DONJOY DEFIANCE III FP
• Type of Device: JOINT, KNEE, EXTERNAL BRACE
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista, ca
• Manufacturer (Section G): DJO, LLC; 3151 scott st.; vista, ca
• Manufacturer Contact: brian becker ; 2900 lake vista drive; lewisville, tx
• MDR Report Key: 9805354
• MDR Text Key: 193378232
• Report Number: 3012446970-2020-00009
• 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: 03/08/2020

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 III FP
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/24/2020
• Initial Date FDA Received: 03/09/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2019
• 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