MAUDE Adverse Event Report: DJO GLOBAL DEFIANCE; JOINT, KNEE, EXTERNAL BRACE

Model Number CONV ADJ OA DEFIANC

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Fall (1848)

Event Date 09/09/2018

Event Type  Injury  

Event Description

It was reported that a patient with medial collateral ligament (mcl) / anterior cruciate ligament (acl) strain and two torn menisci was wearing a don joy defiance custom knee brace.Approximately three months after purchasing the brace, the patient fell while wearing it and reported an "excruciating cracking/snapping/tearing sensation" that was overheard by others.The patient went to the hospital where clinical staff, upon reviewing x-rays,found no breaks.The patient is waiting on another magnetic resonance imaging (mri).Patient had a prior appointment with a physiotherapist to inspect the brace because "it just didn't feel quite right".The physiotherapist had "played around with pad sizes to adjust the fit".

• Brand Name: DEFIANCE
• Type of Device: JOINT, KNEE, EXTERNAL BRACE
• Manufacturer (Section D): DJO GLOBAL; 1430 decision street; vista CA 92081 9663
• Manufacturer (Section G): DJO, LLC; 3151 scott street; vista CA 92081 9663
• Manufacturer Contact: brian becker ; 1430 decision street; vista, CA 92081-9663 ; 7607343126
• MDR Report Key: 7902722
• MDR Text Key: 121493978
• Report Number: 3012446970-2018-00006
• 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,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: CONV ADJ OA DEFIANC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization