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

Model Number CONV DEFIANCE III FP

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

Patient Problems Pain (1994); Swelling (2091)

Event Date 03/19/2019

Event Type  Injury  

Manufacturer Narrative

Device evaluated by mfr: the brace was returned for evaluation.It is in good condition and functional.Per the condition, functionality, and manufacturing form; the brace is built within specifications.No issues were found.

Event Description

It was reported that the patient injured her meniscus while wearing the brace.She was playing roller derby and was stopped at the line.When she went to push off and extended her knee, she felt pain.She followed up with the doctor who performed a previous surgery on the knee.Magnetic resonance imaging (mri) showed no new damage, but she has significant swelling to the meniscus area.No further information was provided.

• Brand Name: DEFIANCE III 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 Key: 8492085
• MDR Text Key: 141223381
• Report Number: 3012446970-2019-00010
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/08/2019

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 III FP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2019
• Initial Date Manufacturer Received: 03/19/2019
• Initial Date FDA Received: 04/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/31/2018
• 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): Hospitalization