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

Model Number CONV DEFIANCE FP

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

Patient Problem Tissue Damage (2104)

Event Date 08/19/2019

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 experienced a grade 3 left medial meniscus tear while wearing the brace.Patient presented on (b)(6) 2019 with "pain in left anteromedial knee after doing a drop during skelly drills at practice and feeling a sharp pain in the knee.He is nine months post-operative anterior cruciate ligament (acl) and functionally tested 100%+ a month prior.He has been doing non-contact drill work for two months.Athlete was braced during the activity.Athlete has tenderness over medial joint line and mild effusion noted after injury.He had full knee range of motion with associated tightness noted in full flexion.Plan: ice, compression, immobilize, rest.(b)(6) 2019: athlete continues with medical [sic] joint line pain and moderate swelling now about the joint[?] he was given a medrol dose pac and meloxicam to help decrease the swelling.(b)(6) 2019: athlete woke up feeling great today with minimal to no swelling and continuing to wear brace.He went to the weight room to do upper body lifting and was rolling out his back when he felt a sharp pain in the left anteromedial joint again and was unable to bear weight on the knee.He was wearing the brace at the time as well and didn't feel like he was doing anything to cause the pain to happen.He had increased swelling and was treated and placed back in a compression and immobilizer brace.No further treatment plan or additional information is currently available.

• Brand Name: DEFIANCE FP
• 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: 9078247
• MDR Text Key: 163116833
• Report Number: 3012446970-2019-00031
• 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: 09/17/2019

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 FP
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/22/2019
• Initial Date FDA Received: 09/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2019
• 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): Hospitalization; Required Intervention