MAUDE Adverse Event Report: DJO LLC. DONJOY FULLFORCE,ACL,SHRT CF,LT,M; JOINT, KNEE, EXTERNAL BRACE

Model Number 11-3221-3

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

Patient Problem Damage to Ligament(s) (1952)

Event Date 01/20/2020

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

It was reported that the patient was "running on the field and pivoted to make a turn during a lacrosse tryout practice while wearing the donjoy knee brace on j(b)(6) 2020." this injury resulted in a complete re-tear of the same knee (left) that the patient had previously torn.This injury resulted in a surgical repair performed on (b)(6) 2020.The device has not been returned to the manufacturer for evaluation.If the device is returned, a follow-up report will be submitted upon completion of device evaluation.

• Brand Name: DONJOY FULLFORCE,ACL,SHRT CF,LT,M
• Type of Device: JOINT, KNEE, EXTERNAL BRACE
• Manufacturer (Section D): DJO LLC.; 1430 decision street; vista, ca
• Manufacturer (Section G): DJO LLC.; 1430 decision street; vista, ca
• Manufacturer Contact: christine bonczyk ; 2900 lake vista drive; lewisville, ca
• MDR Report Key: 10128120
• MDR Text Key: 194314647
• Report Number: 3012446970-2020-00019
• 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: 06/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 11-3221-3
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention