MAUDE Adverse Event Report: DJ ORTHOPEDICS DE MEXICO, S. A. DE C. V. DONJOY ARMOR, ACL, STD, RT, L; JOINT, KNEE, EXTERNAL BRACE

Model Number 11-1444-4

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

Patient Problem Damage to Ligament(s) (1952)

Event Date 09/03/2019

Event Type  Injury  

Manufacturer Narrative

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

Complaint received that alleges that patient "injured left knee during practice while wearing knee braces on both legs.The patient was standing, pass blocking when their right leg gave out.The patient felt a pop." it was reported that the result was a full acl and meniscus tear.The patient would like to have their brace replaced.No additional information is available at this time.

• Brand Name: DONJOY ARMOR, ACL, STD, RT, L
• Type of Device: JOINT, KNEE, EXTERNAL BRACE
• Manufacturer (Section G): DJ ORTHOPEDICS DE MEXICO, S. A. DE C. V.; carretera libre tijuana tecate; 20230 submetropoli el florido; tijuana, b.c., mx 22244 ; MX 22244
• Manufacturer Contact: christine bonczyk ; 2900 lake vista drive; lewisville, ca
• MDR Report Key: 9981348
• MDR Text Key: 192151270
• Report Number: 9616086-2020-00013
• 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
• Report Date: 04/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 11-1444-4
• Date Manufacturer Received: 04/08/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention