MAUDE Adverse Event Report: DJO, LLC DONJOY OA NANO, MEDIAL, RT, S; JOINT, KNEE, EXTERNAL BRACE

Model Number 11-1214-2

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

Patient Problem Swelling (2091)

Event Date 09/21/2018

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 oa nano, medial, rt, s (part number 11-1214-2, lot number 073018) was returned for evaluation.The flexion is hard and the top adjustment screw does not work, but it is not possible to determine if this is related to the complaint reported by the patient.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's leg swelled and turned blue while wearing the brace.

• Brand Name: DONJOY OA NANO, MEDIAL, 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: 8734879
• MDR Text Key: 149206035
• Report Number: 9616086-2019-00038
• 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: Non-Healthcare Professional
• 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: 11-1214-2
• Device Lot Number: 073018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2018
• Initial Date Manufacturer Received: 09/21/2018
• Initial Date FDA Received: 06/26/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/30/2018
• 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