MAUDE Adverse Event Report: ZIMMER KNEE CREATIONS, INC. SUBCHONDROPLASTY ; ORTHOPEDIC TRAY

Lot Number 1016290077

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Cyst(s) (1800); Pain (1994); Ambulation Difficulties (2544)

Event Date 03/17/2015

Event Type  Injury  

Event Description

For a couple of years i had dull, aching pain in my right knee.I finally had an mri and then i had subchondroplasty in (b)(6) 2015 for an intra osseous ganglion cyst in the proximal tibial at the pcl attachment due to a tibial plateau fracture.I had excruciating pain immediately after my anesthesia and pain meds wore off.At f/u appts, i had steroid injections, physical therapy and 4 more surgeries since then, one being a total knee replacement in (b)(6) 2016 and then a revision in (b)(6) 2017.I went from being a weightlifter, runner and doing yoga daily until (b)(6) 2015 to hardly being able to walk.I had spinal fusion in 2009 but that condition had been controlled and tolerable until (b)(6).With the knee pain, difficulty walking, unsteady gait and unable to reach full extension in my right leg.I ended up with a large herniated disc in my spine.I've since been approved for disability as i am unable to find accommodating work.I have an email from the mfr stating that this product would not have been appropriate for my problem since i had a cyst and not a bone lesion.I have most physician, imaging, therapy and operative reports, along with cd images.The salesperson was present in the operating room and he is named in the reports.I had a repeat mri on (b)(6) 2015 and a ct on (b)(6) 2016 which showed an 8mm cyst still present in the same area.Fda safety report id# (b)(4).

• Brand Name: SUBCHONDROPLASTY
• Type of Device: ORTHOPEDIC TRAY
• Manufacturer (Section D): ZIMMER KNEE CREATIONS, INC.
• MDR Report Key: 8793834
• MDR Text Key: 151402659
• Report Number: MW5088155
• Device Sequence Number: 1
• Product Code: OJH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2017
• Device Lot Number: 1016290077
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 40 YR
• Patient Weight: 91