MAUDE Adverse Event Report: DJO, LLC DONJOY 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 07/03/2018

Event Type  Injury  

Manufacturer Narrative

Upon completion of an audit of the dj orthopedics (b)(4).Facility in (b)(4); fda issued a finding on 13 december 2018 that "procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established." this report is being submitted as part of djo's efforts to address this finding.No device was returned for evaluation.If the device is received, a follow-up report will be submitted upon completion of product evaluation.No lot number is available, so no device history record review could be performed.Complaint data for similar products and issues going back 9 months has been reviewed.The trend indicates that reported customer complaints are within control.

Event Description

It was reported that the patient was wearing her brace when an injury occurred.She went straight up to hit a volleyball over the net, came straight down and heard and felt a "pop." she tore her anterior cruciate ligament (acl).Surgery was performed in (b)(6) 2018.

• Brand Name: DONJOY 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 ; 2900 lake vista drive; lewisville, TX 75067
• MDR Report Key: 8734877
• MDR Text Key: 149203889
• Report Number: 9616086-2019-00035
• 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: 06/26/2019

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: 07/18/2018
• Initial Date FDA Received: 06/26/2019
• 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