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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 06/12/2019
Event Type  Injury  
Manufacturer Narrative
Health professional, occupation: unknown.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 partially tore his repaired anterior cruciate ligament (acl) while wearing the brace.The patient is a high school baseball player and was sliding into a base with the right leg and caught his knee awkwardly on the base, re-injuring his knee.It has been diagnosed as a partial acl tear.No surgery is scheduled; the patient will rehabilitate his knee with physical therapy.No further information was provided.
 
Manufacturer Narrative
H3, h6: updated with device evaluation information: the product was evaluated 13 may 2020 and found that the brace dimensions were within specifications.
 
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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
MDR Report Key8772708
MDR Text Key150453515
Report Number3012446970-2019-00020
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,Followup
Report Date 06/03/2020
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 NumberCONV DEFIANCE FP
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/21/2020
Initial Date Manufacturer Received 06/12/2019
Initial Date FDA Received07/09/2019
Supplement Dates Manufacturer Received06/12/2019
Supplement Dates FDA Received06/10/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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