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

Model Number N/A

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

Patient Problem Pulmonary Embolism (1498)

Event Date 11/26/2020

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 remains implanted.The product was evaluated through manufacturing review and the reported event was confirmed through review of medical records.The device history records were reviewed and no discrepancies were identified.Procedural related complications are influenced by the type of surgery, patients pre-existing comorbid state, and perioperative management.If a blood clot breaks free, it may travel through the bloodstream and block blood flow to the lungs, resulting in a pulmonary embolism (pe).Total joint patients are typically placed on medication post-operatively for a period of time to help prevent the development of blood clot formation that can lead to pe.Based on the information provided, the root cause is attributed to be procedure-related.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.

Event Description

It is reported that the patient developed a pulmonary embolism within one (1) following a right knee subchondroplasty procedure and was treated orally.The patient's treatment was reported to be ongoing.

• Brand Name: KNEE CREATIONS SUBCHONDROPLASTY KNEE KIT 5CC END -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: 11092433
• MDR Text Key: 224253389
• Report Number: 3008812173-2020-00024
• Device Sequence Number: 1
• Product Code: OJH
• UDI-Device Identifier: 00889024205321
• UDI-Public: (01)00889024205321
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/30/2022
• Device Model Number: N/A
• Device Catalogue Number: 414.503
• Device Lot Number: KC06079
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/07/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2019
• 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: 61 YR
• Patient Weight: 95