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U.S. Department of Health and Human Services

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

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DJO, LLC DEFIANCE FP; JOINT, KNEE, EXTERNAL BRACE Back to Search Results
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.
 
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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 Key8375715
MDR Text Key137316103
Report Number3012446970-2019-00005
Device Sequence Number1
Product Code ITQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
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 NumberCONV DEFIANCE FP
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/25/2019
Initial Date Manufacturer Received 02/05/2019
Initial Date FDA Received02/27/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/15/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age17 YR
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