MAUDE Adverse Event Report: DJO LLC. DONJOY TITANIUM, A22; JOINT, KNEE, EXTERNAL BRACE

Model Number CONV TITANIUM

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

Patient Problem Damage to Ligament(s) (1952)

Event Date 11/30/2019

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 "playing in a high school basketball game and had her a22 brace on.She went up for a layup and felt a pop.She saw her local orthopedic surgeon that night.She had an mri two days later that showed a complete re-tear of her left acl graft.She had surgery.On (b)(6) 2019 for a second repair.".

• Brand Name: DONJOY TITANIUM, A22
• 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: 9957696
• MDR Text Key: 193661450
• Report Number: 3012446970-2020-00014
• 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: 04/13/2020

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: CONV TITANIUM
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/06/2020
• Initial Date FDA Received: 04/14/2020
• 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