MAUDE Adverse Event Report: ZIMMER KNEE CREATIONS, INC. SUBCHONDROPLASTY KNEE KIT 5CC SIDE-DELIVERY 11GA. X 120MM; FILLER, BONE

Model Number N/A

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

Patient Problems Pain (1994); Non-union Bone Fracture (2369); Numbness (2415); Ambulation Difficulties (2544); Osteopenia/ Osteoporosis (2651); Decreased Sensitivity (2683); Swelling/ Edema (4577)

Event Date 10/18/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the device was used.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.This report was previously submitted erroneously on nov 14, 2018 and may 24, 2021 under manufacturing report number 0001225112-2018-00004.Investigation incomplete.

Event Description

It was reported that the patient underwent a subchondroplasty surgical procedure to address a non-displaced tibial plateau fracture, but continued to experience pain and further reported worsening pain while at rest and during ambulation, numbness and temperature changes in the knee, achiness, swelling and instability that required crutches and a knee brace.The patient was referred to multiple doctors and diagnosed with complex regional pain syndrome.Approximately two (2) years following the subchondroplasty, the patient received a stimulator placement for treatment of chronic pain.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The device history records were reviewed and no discrepancies were identified.Medical records received were reviewed and previously reported.Per the instructions for use (ifu) associated with the device, the device is not intended to be used for patients with metabolic bone disease, altered calcium metabolism.The root cause of the reported issue was determined to be off-label use.A summary of the investigation was sent to the complainant conveying proper surgical technique and use of the device.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: SUBCHONDROPLASTY KNEE KIT 5CC SIDE-DELIVERY 11GA. X 120MM
• Type of Device: FILLER, BONE
• Manufacturer (Section D): ZIMMER KNEE CREATIONS, INC.; 841 springdale drive; exton PA 19341
• Manufacturer (Section G): ZIMMER KNEE CREATIONS, INC.; 841 springdale drive; exton PA 19341
• Manufacturer Contact: leo munar ; 841 springdale drive; exton, PA 19341 ; 4848794553
• MDR Report Key: 12561126
• MDR Text Key: 274222164
• Report Number: 3008812173-2021-00003
• Device Sequence Number: 1
• Product Code: OJH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/13/2019
• Device Model Number: N/A
• Device Catalogue Number: 414.502
• Device Lot Number: KC03101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 41 YR
• Patient Sex: Female
• Patient Weight: 88 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White