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 03/06/2019

Event Type  Injury  

Manufacturer Narrative

The customer did not indicate that the device will be returned for evaluation.If the device is returned to the manufacturer, a supplemental report will be submitted upon completion of device evaluation.

Event Description

It was reported that "athlete/writer was wearing brace while playing soccer game, was dribbling ball and made pivot/turn in which knee gave out and bent in an abnormal way, leading to instant pain and swelling of knee.It was later discovered that she tore her acl (anterior cruciate ligament) again.She had surgery on (b)(6) 2019.".

• Brand Name: DONJOY TITANIUM, A22
• Type of Device: JOINT, KNEE, EXTERNAL BRACE
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081 9663
• Manufacturer (Section G): DJO, LLC; 3151 scott st.; vista CA 92081 9663
• Manufacturer Contact: brian becker ; 2900 lake vista drive; lewisville, TX 75067
• MDR Report Key: 8662582
• MDR Text Key: 146803775
• Report Number: 3012446970-2019-00013
• 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: 06/03/2019

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: CONV TITANIUM
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/13/2019
• Initial Date FDA Received: 06/03/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2019
• 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