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

Model Number CONV TITANIUM

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Damage to Ligament(s) (1952)

Event Date 01/25/2019

Event Type  Injury  

Manufacturer Narrative

Device available for evaluation, event problem and evaluation codes: brace specifications and order forms were confirmed to be consistent with a left knee brace, which is the knee for which the brace was intended.However, it was confirmed by photograph that the brace provided to the sales person in association with this event was a right brace.

Event Description

The customer reported that the patient re-tore her anterior cruciate ligament (acl) and meniscus while wearing the brace.The patient was warming up for a basketball game on (b)(6) 2019 when she twisted her knee while wearing the brace.She continued playing.Patient had swelling the next day in the left knee.On (b)(6) 2019, patient complained of tweaking her knee again while playing basketball.The patient reportedly experienced previous minor skin irritation and that the brace was ill-fitting.On (b)(6) 2019, the sales representative discovered that the brace was constructed for the right knee instead of the left knee.The patient wore a playmaker brace on the night of (b)(6) 2019.On (b)(6) 2019, magnetic resonance imaging (mri) showed a re-tear of the acl and meniscus.Revision surgery was scheduled for (b)(6) 2019.No further information was provided.

Manufacturer Narrative

One conv titanium, 22 brace with serial number (b)(4) was returned for evaluation.Hinges are sticking when brace is being flexed.Hinges have some type of foreign glue inside the hinge housing which is not part of our process when building the brace.Conclusions are as follows: per the manufacturing form, the brace should be a left leg and manufacturing built a right leg incorrectly.Lateral side thigh frame bar is rubbing against plastic hinge cover.Per the manufacturing form and drawing, thigh frame knee width is out of specifications.Per design engineering statement, the brace is malleable and can be adjusted by user; however, knee width would not contribute to an anterior cruciate ligament (acl) injury.Lateral side and medial side have some type of foreign glue inside the hinge housing which is not part of our process when building the brace.Mechanism in both hinges can't function properly being exposed to foreign glue.

• Brand Name: TITANIUM, A22
• Type of Device: JOINT, KNEE, EXTERNAL BRACE
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081 9663
• MDR Report Key: 8432305
• MDR Text Key: 139195624
• Report Number: 3012446970-2019-00007
• 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: 05/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CONV TITANIUM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2019
• Date Manufacturer Received: 03/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNSPECIFIED PLAYMAKER BRACE; UNSPECIFIED PLAYMAKER BRACE
• Patient Outcome(s): Required Intervention
• Patient Age: 17 YR
• Patient Weight: 50