MAUDE Adverse Event Report: DJO, LLC ARMOR FP,ACL,RT,S; CAGE, KNEE

Model Number 11-1440-2

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Damage to Ligament(s) (1952)

Event Date 12/08/2018

Event Type  Injury  

Manufacturer Narrative

Initial reporter occupation: unknown.There is no indication from the customer that the device will be returned for evaluation.

Event Description

It was reported that "there was 51 seconds left of the game, [name redacted] was bringing the ball up the court and the opposing team tried to steal the ball.The ball got loose and (b)(6) dove after it.During the dive after the ball her right knee twisted, she rolled over and grabbed her knee.She was helped off the court and assessed by their athletic trainer.This led to the retear of her acl (anterior cruciate ligament).She was wearing her brace and has always wore her brace during practices and games as well as any athletic events that she was participating in." no further information is available at the time of this report.

• Brand Name: ARMOR FP,ACL,RT,S
• Type of Device: CAGE, KNEE
• 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, b.c. 22244, ; MX
• Manufacturer Contact: brian becker ; 1430 decision street; vista, CA 92081-9663 ; 7607343126
• MDR Report Key: 8357390
• MDR Text Key: 136732422
• Report Number: 9616086-2019-00007
• Device Sequence Number: 1
• Product Code: ITM
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 11-1440-2
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/28/2019
• 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): Required Intervention