MAUDE Adverse Event Report: DJO, LLC DONJOY ARMOR FP, ACL,STD,RT,XL; JOINT, KNEE, EXTERNAL BRACE

Model Number 11-1442-5

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

Patient Problem Damage to Ligament(s) (1952)

Event Date 01/02/2020

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 "tore his acl (anterior cruciate ligament) while in this brace during a football game.He fell one way and his right knee stayed and he felt a pop happen." no further information is currently available.

Manufacturer Narrative

Corrected data: d4 serial number.H3, h6: the product was received without components (straps, buckles, etc.).A visual inspection was made, no damage to the structure or components is observed.The brace appears to have been used; the flexion is good, the problem reported by the customer could not be confirmed.A trend has not been identified.Complaint data for similar products and issues going back six months has been reviewed.The data indicates customer complaints reported are within control.

• Brand Name: DONJOY ARMOR FP, ACL,STD,RT,XL
• Type of Device: JOINT, KNEE, EXTERNAL BRACE
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081
• MDR Report Key: 9580981
• MDR Text Key: 174735272
• Report Number: 9616086-2020-00004
• 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: 03/30/2020

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: 11-1442-5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2020
• Initial Date Manufacturer Received: 01/02/2020
• Initial Date FDA Received: 01/13/2020
• Supplement Dates Manufacturer Received: 01/02/2020
• Supplement Dates FDA Received: 03/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention