MAUDE Adverse Event Report: DJO, LLC DONJOY FULLFORCE,ACL,STD,CALF,LT,M; JOINT, KNEE, EXTERNAL BRACE

Model Number 11-0259-3

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

Patient Problem Damage to Ligament(s) (1952)

Event Date 07/06/2018

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.One fullforce,acl,std,calf,lt,m (part number 11-0259-3, lot number 011818) was returned for evaluation.The product was evaluated.All the components are in good condition.Flexion is good.No problem or fault was found.The device history record (dhr) was reviewed for the reported product.There was no information in the dhr that would indicate a problem that contributed to the reported complaint.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 working as a police officer and was attempting to subdue a suspect.Patient was running toward the suspect and believed the police canine to be on his leash.As the patient was running toward the suspect, the canine focused on the patient and he was not on his leash.The canine went toward the patient, forcing the patient to attempt to stop quickly.The patient was on grass when attempting to stop.Both of the patient's knees buckled and slid underneath as the patient fell to the ground.The canine then proceeded to attack the patient.Upon standing up, the patient's knee was in extreme discomfort.The patient was wearing the brace at the time of the incident.Magnetic resonance imaging (mri) confirmed the anterior cruciate ligament (acl) and posterior cruciate ligament (pcl) were torn.Surgery was conducted to repair both ligaments, followed by an eventual second surgery to remove scar tissue.The patient reportedly had 114 physical therapy sessions before returning to work and was prescribed pain medication along with anti-inflammatory medication following the incident.

• Brand Name: DONJOY FULLFORCE,ACL,STD,CALF,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: 8734864
• MDR Text Key: 149204622
• Report Number: 9616086-2019-00034
• Device Sequence Number: 1
• Product Code: ITQ
• Combination Product (y/n): N
• PMA/PMN Number: EXERMPT
• 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: 11-0259-3
• Device Lot Number: 011818
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2018
• Initial Date Manufacturer Received: 07/12/2018
• Initial Date FDA Received: 06/26/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2018
• 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