MAUDE Adverse Event Report: DJO, LLC DONJOY FULLFORCE,ACL,STD,CALF,RT,XS; JOINT, KNEE, EXTERNAL BRACE

Model Number 11-0258-1

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

Patient Problem Damage to Ligament(s) (1952)

Event Date 10/06/2018

Event Type  Injury  

Manufacturer Narrative

Device evaluated by mfr: the device has not been received.If the device is returned, a follow-up report will be submitted with evaluation results.

Event Description

It was reported that, while playing in a (b)(6) basketball game, the patient re-tore a previously torn anterior cruciate ligament along with tearing her medial meniscus.The patient received the brace that was being worn at the time of the injury in (b)(6) 2018.This brace was prescribed by her orthopedic surgeon.Additional information was requested, but not provided.

Manufacturer Narrative

Anterior cruciate ligament (acl) surgery and meniscal repair was performed on the patient following the incident.Outcome was not provided.

• Brand Name: DONJOY FULLFORCE,ACL,STD,CALF,RT,XS
• Type of Device: JOINT, KNEE, EXTERNAL BRACE
• Manufacturer (Section D): DJO, LLC; 1430 decision st.; vista CA 92081 9663
• MDR Report Key: 8459475
• MDR Text Key: 140147395
• Report Number: 9616086-2019-00013
• 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,Followup
• Report Date: 05/06/2019

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: 11-0258-1
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/05/2019
• Initial Date FDA Received: 03/28/2019
• Supplement Dates Manufacturer Received: 04/15/2019
• Supplement Dates FDA Received: 05/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 18 YR