MAUDE Adverse Event Report: DJO, LLC FULLFORCE,ACL,SHRT CF,RT,L; JOINT, KNEE, EXTERNAL BRACE

Model Number 11-3220-4

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

Patient Problem Damage to Ligament(s) (1952)

Event Date 11/28/2018

Event Type  Injury  

Manufacturer Narrative

The device has not been returned for evaluation and there is no indication from the customer that it will be returned as such.If the device is returned, a follow-up report will be submitted with investigation results.

Event Description

The patient reported that while skiing, they turned to stop and went slightly off balance then twisted the right knee a little bit.The patient reportedly felt a pop and fell down.The patient tore the anterior cruciate ligament (acl).No further information was provided.

• Brand Name: FULLFORCE,ACL,SHRT CF,RT,L
• 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: 8375937
• MDR Text Key: 137362863
• Report Number: 9616086-2019-00008
• 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: 02/27/2019

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: 11-3220-4
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/06/2019
• Initial Date FDA Received: 02/27/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention