MAUDE Adverse Event Report: DJO, LLC DONJOY TITANIUM, A22; JOINT, KNEE, EXTERNAL BRACE

Model Number CONV TITANIUM

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

Patient Problem Damage to Ligament(s) (1952)

Event Date 09/05/2018

Event Type  Injury  

Manufacturer Narrative

Occupation: unknown.

Event Description

It was reported that, while playing basketball at a friend's house, the patient went up to dunk and when he came down, there was an audible pop.The patient sustained a complete tear of the anterior cruciate ligament (acl) while wearing the brace.There was reportedly no meniscus damage.The tear was described as a re-injury.

Manufacturer Narrative

The device is not available for evaluation.Should the device become available as such, a follow-up report will be submitted.

• Brand Name: DONJOY TITANIUM, A22
• Type of Device: JOINT, KNEE, EXTERNAL BRACE
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081 9663
• MDR Report Key: 8259073
• MDR Text Key: 133464038
• Report Number: 3012446970-2019-00001
• 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: company representative,other
• Type of Report: Initial,Followup
• Report Date: 01/17/2019

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 TITANIUM
• Device Lot Number: A20150504015R03
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/04/2019
• Initial Date FDA Received: 01/17/2019
• Supplement Dates Manufacturer Received: 01/04/2019
• Supplement Dates FDA Received: 01/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention