MAUDE Adverse Event Report: DJO, LLC; KNEE BRACE

Model Number 11-1440-4

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

Patient Problem Complaint, Ill-Defined (2331)

Event Date 10/24/2014

Event Type  Injury  

Event Description

Service of notification from lawyer was manufacturers first notification of this event.Plaintiffs counsel claims in the complaint that "personal injuries based on negligence arising from the fact that you company, provide an improper and inadequate brace for our client's condition and known activity level, which resulted in serious injuries".Questionnaire not received from clinician and/or patient.Device not returned to manufacturer for evaluation.

Manufacturer Narrative

Additional data received from the patient/clinician as follows': i've researched (b)(6)'s brace history: (b)(6) was first seen by dr.(b)(6) on (b)(6) 2013 for torn acl and torn lateral meniscus, playing football (non-contact injury).He was not a (b)(6) football player then and played for a high school team.He had surgery on (b)(6) 2013 for the said injury.Post-op appointments followed on (b)(6) 2013.Initial brace order was (b)(6) 2014 to be used for seven on seven drills.(b)(6) 2014 - six months post op, he was cleared to start some cutting drills with his brace.(b)(6) 2014 - ten months post op, (b)(6) mentioned that he has no problems with the brace other than it was slipping.The plan was to get his brace fitted properly and he was cleared to play football with his brace.(b)(6) 2014 - (b)(6) returned to clinic with torn acl allograft and small medial meniscal tear.He also has post-op changes from the partial lateral meniscectomy.(b)(6) 2015 - he is back in clinic with his mother, this is the first time that he mentioned that he was not given the correct brace for his activities, as the brace bent.Court summons received indicated injury sustained as follows: as a proximate result the plaintiff sustained a second torn medial collateral ligament requiring the plaintiff to undergo a second surgery which has caused the plaintiff serious and disabling physical injuries and damages, device not returned.

• Type of Device: KNEE BRACE
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081 9663
• Manufacturer (Section G): DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.; carretera libre tijuana tecate; 20230 submetropoli el florido; tijuana, mexico 22244 ; MX 22244
• Manufacturer Contact: william fisher ; 1430 decision street; vista, CA 92081 ; 7607313126
• MDR Report Key: 5471012
• MDR Text Key: 39379626
• Report Number: 9616086-2016-00006
• Device Sequence Number: 1
• Product Code: ITQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/01/2016

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: 11-1440-4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/12/2016
• Initial Date FDA Received: 03/01/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other