MAUDE Adverse Event Report: DJO, LLC DONJOY DEFIANCE STD; JOINT, KNEE, EXTERNAL BRACE

Model Number CONV DEFIANCE STD

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

Patient Problem Damage to Ligament(s) (1952)

Event Date 09/08/2018

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 re-tore his anterior cruciate ligament (acl) while wearing his brace and playing an unspecified sport.He was reportedly "doing everything he was told to do and had it on correctly".He has "rehabbed and finally cleared to play again".The surgery for the re-ruptured acl was on 01 october 2018.The patient will be seen by the doctor and/or sales rep to be fit remeasured for a new brace.

Manufacturer Narrative

One conv defiance std 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: DONJOY DEFIANCE STD
• Type of Device: JOINT, KNEE, EXTERNAL BRACE
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081 9663
• MDR Report Key: 8790086
• MDR Text Key: 151021547
• Report Number: 3012446970-2019-00021
• 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 STD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2019
• Initial Date Manufacturer Received: 06/20/2019
• Initial Date FDA Received: 07/15/2019
• Supplement Dates Manufacturer Received: 06/20/2019
• 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
• Patient Age: 16 YR