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

Model Number 11-1442-3

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

Patient Problem Damage to Ligament(s) (1952)

Event Date 11/30/2017

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,std,rt,m (part number 11-1442-3, lot number 040417) was returned for evaluation.The product was visually evaluated.The brace has excessive use; the hinge hook was found unglued, but it cannot be determined if this was the cause of the problem reported by the customer.The flexion is sufficient.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 playing basketball while wearing her armor fp brace.She was playing defense, went to cut, felt a "pop", and fell to the ground.She re-tore her anterior cruciate ligament (acl).

• Brand Name: DONJOY ARMOR FP, ACL,STD,RT,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: 8734870
• MDR Text Key: 149205254
• Report Number: 9616086-2019-00028
• 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: 11-1442-3
• Device Lot Number: 070417
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2018
• Initial Date Manufacturer Received: 01/29/2018
• Initial Date FDA Received: 06/26/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2017
• 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