MAUDE Adverse Event Report: DJO, LLC ARMOR FP,ACL,LT,M; JOINT, KNEE, EXTERNAL BRACE

Model Number 11-1441-3

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

Patient Problem Damage to Ligament(s) (1952)

Event Date 02/04/2019

Event Type  Injury  

Manufacturer Narrative

The customer did not indicate that the device will be returned.If the device is returned, a supplemental report will be submitted upon completion of the evaluation.

Event Description

It was reported that, while playing in a basketball game, the patient tore her anterior cruciate ligament (acl) for the second time.She was wearing her armour fourcepoint brace.She was going after a loose ball.When she planted her left foot, she felt pain and fell to the floor.There was no contact with any other player.Additional information was requested but no response was received.

• Brand Name: ARMOR FP,ACL,LT,M
• Type of Device: JOINT, KNEE, EXTERNAL 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, b.c. 22244, ; MX
• Manufacturer Contact: brian becker ; 1430 decision street; vista, CA 92081-9663 ; 7607343126
• MDR Report Key: 8424705
• MDR Text Key: 138926687
• Report Number: 9616086-2019-00011
• Device Sequence Number: 1
• Product Code: ITQ
• 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: 03/14/2019

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: 11-1441-3
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/20/2019
• Initial Date FDA Received: 03/15/2019
• 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