MAUDE Adverse Event Report: DJO, LLC DONJOY ARMOR FP,ACL,RT,S; JOINT, KNEE, EXTERNAL BRACE

Model Number 11-1440-2

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

Patient Problem Damage to Ligament(s) (1952)

Event Date 10/19/2017

Event Type  Injury  

Manufacturer Narrative

Upon completion of an audit of the dj orthopedics (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.Device evaluated by mfr: one armor fp,acl,rt,s (part number 11-1440-2) was returned for evaluation.The product was evaluated.Item was used, product is dirty, hooks of the hinge are unglued, the flexion on the hinges is hard, functionally is not good.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 participating in drills at soccer practice.She was wearing her brace.She planted her foot to make a turn and the knee buckled, re-tearing her anterior cruciate ligament (acl).The patient had acl and meniscus repair surgeries performed in (b)(6) 2017 and (b)(6) 2018.

• Brand Name: DONJOY ARMOR FP,ACL,RT,S
• 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: 8734866
• MDR Text Key: 149204717
• Report Number: 9616086-2019-00031
• 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: 06/25/2019

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: 11-1440-2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2018
• Initial Date Manufacturer Received: 01/30/2018
• Initial Date FDA Received: 06/26/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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