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

Model Number 11-3221-3

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

Patient Problem Damage to Ligament(s) (1952)

Event Date 08/30/2019

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 working one on one with her assistant coach.She was jumping at the net and when she landed she knew it was injured.We saw her surgeon at saturday clinic the next morning where the sent her for mri (magnetic resonance imaging) and confirmed acl (anterior cruciate ligament) was torn".

• Brand Name: DONJOY FULLFORCE,ACL,SHRT CF,LT,M
• 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: 9659548
• MDR Text Key: 179264303
• Report Number: 9616086-2020-00007
• 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: 02/01/2020

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: 11-3221-3
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/21/2020
• Initial Date FDA Received: 02/03/2020
• 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