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

Model Number CONV DEFIANCE FP

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

Patient Problem Damage to Ligament(s) (1952)

Event Date 07/15/2019

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 re-tore anterior cruciate ligament (acl) / medial collateral ligament (mcl) / meniscus playing football.No further information was provided.

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: DONJOY DEFIANCE FP
• Type of Device: JOINT, KNEE, EXTERNAL BRACE
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081 9663
• MDR Report Key: 8875515
• MDR Text Key: 153799966
• Report Number: 3012446970-2019-00026
• 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: distributor
• 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: Health Professional
• Device Model Number: CONV DEFIANCE FP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2019
• Initial Date Manufacturer Received: 07/15/2019
• Initial Date FDA Received: 08/08/2019
• Supplement Dates Manufacturer Received: 07/15/2019
• 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