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
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pulmonary Embolism (1498)
Date of Event	11/26/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: FILLER, BONE
• Manufacturer (Section D): ZIMMER KNEE CREATIONS, INC.; 841 springdale drive; exton PA 19341
• MDR Report Key: 11092433
• Report Number: 3008812173-2020-00024
• Device Sequence Number: 632282
• Product Code: OJH
• UDI-Device Identifier: 00889024205321
• UDI-Public: (01)00889024205321
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/29/2020

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
• Operator of Device: 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
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2020
• Initial Report FDA Received Date: 12/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Weight: 95