MAUDE Adverse Event Report: DJO LLC. DONJOY DEFIANCE III FP; JOINT, KNEE, EXTERNAL BRACE

Model Number CONV DEFIANCE III FP WITH HINGES

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

Patient Problem Damage to Ligament(s) (1952)

Event Date 02/21/2020

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 injured during a basketball game on (b)(6) 2020 while wearing his donjoy brace exactly 17 months after his left acl surgery.As he "proceeded to run down the court for a fast break the basketball was passed to him and he planted his left food to jump up to complete a layup and as this happened, he felt a tear.Follow-up mri (magnetic resonance image) appointment on (b)(6) 2020 confirmed that the patient's left acl graft was torn.It was reported that the patient had surgery to repair his left acl graft, his medial and lateral meniscus, as well as his anterolateral ligament on (b)(6) 2020.Device has not been received manufacturer at this time.Manufacturer is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.No additional information is currently available.

• Brand Name: DONJOY DEFIANCE III FP
• Type of Device: JOINT, KNEE, EXTERNAL BRACE
• Manufacturer (Section D): DJO LLC.; 1430 decision street; vista, ca
• Manufacturer (Section G): DJO LLC; 3151 scott street; vista, ca
• Manufacturer Contact: christine bonczyk ; 2900 lake vista drive; lewisville, ca
• MDR Report Key: 9964814
• MDR Text Key: 193661986
• Report Number: 3012446970-2020-00015
• 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: 04/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: CONV DEFIANCE III FP WITH HINGES
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/13/2020
• 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