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

Model Number 11-0258-2

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

Patient Problem Damage to Ligament(s) (1952)

Event Date 11/20/2019

Event Type  Injury  

Manufacturer Narrative

No device was returned for evaluation.If the device is received, a follow-up report will be submitted upon completion of product evaluation.

Event Description

It was reported that the patient "was wearing his brace on right knee due to previous acl (anterior cruciate ligament) surgery, during basketball practice.He was running down the court and went to turn when he felt a "pop" in his right knee followed by minor pain.We called his surgeon the following day and he was seen in his office 1 week later.Had mri (magnetic resonance imagery) done on (b)(6) 2019 which showed a complete tear of right acl graft.Saw surgeon on (b)(6) 2019 and had repeat surgery on (b)(6) 2019.".

• Brand Name: DONJOY FULLFORCE,ACL,STD,CALF,RT,S
• Type of Device: JOINT, KNEE, EXTERNAL BRACE
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081
• 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 22244
• Manufacturer Contact: brian becker ; 2900 lake vista drive; lewisville, TX 75067
• MDR Report Key: 9580987
• MDR Text Key: 174735482
• Report Number: 9616086-2020-00003
• 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: 01/13/2020

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: 11-0258-2
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/31/2019
• Initial Date FDA Received: 01/13/2020
• 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