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 07/24/2019

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 "went to play basketball at a rec center.I put on my a-22 series brace.This was sized to my leg.I started to warm up, dribbling and everything.I then started to hop in the air and landing on my left leg (leg with the injury).I did that about 4-5 times.Everything felt good and stable so i started to play around.I went up to the basket a couple times no problem.Then about the 3rd time i went up my body kinds rotated in the air.No one hit me; it was just me.When i landed, i re-tore my acl (anterior cruciate ligament)".[sic] no further information is currently available.

Manufacturer Narrative

One conv titanium, a22 brace, serial number (b)(4), was returned for evaluation.The brace is in good condition and functional.Per the brace manufacturing form and drawing, the calf frame knee width is out of specification.Per design engineering, the brace is malleable and can be adjusted by the user; however, knee width would not contribute to an anterior cruciate ligament (acl) injury.The failure is not related to the event.

• Brand Name: DONJOY TITANIUM, A22
• Type of Device: JOINT, KNEE, EXTERNAL BRACE
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081 9663
• MDR Report Key: 9118549
• MDR Text Key: 164707541
• Report Number: 3012446970-2019-00035
• 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,Followup
• Report Date: 12/23/2019

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2019
• Initial Date Manufacturer Received: 09/03/2019
• Initial Date FDA Received: 09/25/2019
• Supplement Dates Manufacturer Received: 09/03/2019
• Supplement Dates FDA Received: 12/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention