MAUDE Adverse Event Report: DJO, LLC DEFIANCE FP PLUS; JOINT, KNEE, EXTERNAL BRACE

Model Number CONV DEFIANCE FP PLUS HINGES

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

Patient Problem Damage to Ligament(s) (1952)

Event Date 01/19/2019

Event Type  Injury  

Manufacturer Narrative

The reporter gave no indication that the device will be returned to the manufacturer for evaluation.If the device is returned, a follow-up report will be submitted upon completion of device evaluation.

Event Description

It was reported that the patient re-tore his anterior cruciate ligament (acl) while wearing the brace.He was participating in basketball when he was driving to the baseline and he planted his left foot to jump.His left knee proceeded to give out and buckle, thus resulting in a re-tear of the acl.No further information was provided at this time.

Manufacturer Narrative

One conv defiance fp brace, serial number (b)(4).Was returned for evaluation.The brace is in good condition and functional.Per the condition, functionality, and manufacturing form, the brace is built within specifications.No issues were found.

• Brand Name: DEFIANCE FP PLUS
• Type of Device: JOINT, KNEE, EXTERNAL BRACE
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081 9663
• MDR Report Key: 8478566
• MDR Text Key: 140772484
• Report Number: 3012446970-2019-00008
• 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 DEFIANCE FP PLUS HINGES
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2019
• Initial Date Manufacturer Received: 02/05/2019
• Initial Date FDA Received: 04/03/2019
• Supplement Dates Manufacturer Received: 02/05/2019
• 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