MAUDE Adverse Event Report: DJO, LLC TITANIUM, A22; JOINT, KNEE, EXTERNAL BRACE

Model Number CONV TITANIUM

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

Patient Problem Damage to Ligament(s) (1952)

Event Date 12/06/2018

Event Type  Injury  

Event Description

It was reported that, while playing in a basketball game, the patient changed direction on her left leg and she heard a pop and went down.Three days later, she had a magnetic resonance image (mri) and it showed that the graph used to repair her anterior cruciate ligament (acl) in (b)(6) 2018 had ruptured.She had surgery on (b)(6) to repair it.

Manufacturer Narrative

One brace was returned for evaluation.The brace is in good condition and functional.The thigh frame knee width and calf frame knee width are out of specifications.The brace is malleable and can be adjusted by the user; however, knee width would not contribute to an acl (anterior cruciate ligament) injury.The cause of the adverse event was not determined.

• Brand Name: TITANIUM, A22
• Type of Device: JOINT, KNEE, EXTERNAL BRACE
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081 9663
• MDR Report Key: 8289324
• MDR Text Key: 134491066
• Report Number: 3012446970-2019-00004
• Device Sequence Number: 1
• Product Code: ITQ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 01/30/2019

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 TITANIUM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2019
• Initial Date Manufacturer Received: 01/23/2019
• Initial Date FDA Received: 01/30/2019
• Supplement Dates Manufacturer Received: 01/23/2019
• Supplement Dates FDA Received: 01/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention