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 05/14/2019

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 "was doing her prescribed physical therapy exercises at home.She was wearing her donjoy brace at the time.She had been told to do some plyometric type exercises - jump squats, etc., to prepare her to return to playing soccer.She squatted down and when she jumped, her acl popped and had an 80% re-tear that required it to be surgically fixed again".No further information is currently available.

Manufacturer Narrative

H3, h6: one titanium, a22 (serial number: (b)(6) 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 TITANIUM, A22
• Type of Device: JOINT, KNEE, EXTERNAL BRACE
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081 9663
• MDR Report Key: 9144982
• MDR Text Key: 162085510
• Report Number: 3012446970-2019-00036
• 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: 01/30/2020

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: CONV TITANIUM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2020
• Initial Date Manufacturer Received: 09/05/2019
• Initial Date FDA Received: 10/02/2019
• Supplement Dates Manufacturer Received: 09/05/2019
• Supplement Dates FDA Received: 01/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention