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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DJO, LLC DONJOY DEFIANCE FP; JOINT, KNEE, EXTERNAL BRACE
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DJO, LLC DONJOY 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 05/16/2019
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 re-tore his anterior cruciate ligament (acl) while playing football and wearing the brace.Patient had the initial injury while playing basketball (b)(6) 2018.No further information was provided.
 
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Brand Name
DONJOY 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 Key8870747
MDR Text Key153573905
Report Number3012446970-2019-00025
Device Sequence Number1
Product Code ITQ
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial
Report Date 08/07/2019
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? No
Initial Date Manufacturer Received 07/11/2019
Initial Date FDA Received08/07/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/24/2019
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 Age13 YR
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