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

Model Number CONV DEFIANCE FP

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

Patient Problem Injury (2348)

Event Date 02/18/2020

Event Type  Injury  

Manufacturer Narrative

Reporter information: 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 with a previous anterior cruciate ligament injury "pivoted playing frisbee and tore the meniscus while wearing the brace." the brace would reportedly "slide a bit during running." no further information is currently available.

• Brand Name: DONJOY DEFIANCE FP
• Type of Device: JOINT, KNEE, EXTERNAL BRACE
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista, ca
• Manufacturer (Section G): DJO, LLC; 3151 scott st.; vista, ca
• Manufacturer Contact: brian becker ; 2900 lake vista drive; lewisville, tx
• MDR Report Key: 9764685
• MDR Text Key: 182180616
• Report Number: 3012446970-2020-00005
• Device Sequence Number: 1
• Product Code: ITQ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2020
• 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
• Date Manufacturer Received: 02/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2017
• 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