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 Damage to Ligament(s) (1952)

Event Date 01/18/2019

Event Type  Injury  

Manufacturer Narrative

The brace was returned for evaluation and found to be built within specifications.No issues were found.

Event Description

It was reported that, on (b)(6) 2019, the patient was playing basketball and was noticed to be on the floor crying.She was helped off the court, checked, and she iced her knee.She was still hurting the next morning and went to the doctor.On (b)(6) 2019, magnetic resonance imaging (mri) was performed and she was diagnosed with a tear of the anterior cruciate ligament (acl) graft and tear of the lateral meniscus and medial meniscus of the right knee.The patient was scheduled for follow-up surgery.No further information was provided.

• 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 ; 1430 decision street; vista, CA 92081-9663 ; 7607343126
• MDR Report Key: 8375715
• MDR Text Key: 137316103
• Report Number: 3012446970-2019-00005
• Device Sequence Number: 1
• Product Code: ITQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/27/2019

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2019
• Initial Date Manufacturer Received: 02/05/2019
• Initial Date FDA Received: 02/27/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2018
• 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
• Patient Age: 17 YR