MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIAL COMPONENT PRECOAT SIZE 6; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.No devices or medical records were received.Device history record (dhr) was reviewed and no discrepancies were found.It was noted that the surgeon did not have enough bone cement available during the procedure, and had initially implanted the devices without cement, which is an off-label use of the devices.He then re-implanted the devices 4 hours later with cement.Instructions for device use state to not sue this product for other than labeled indications and are for single use only.The root cause of the reported issue is user error.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.Concomitant medical products: 00585004301, femoral component, lot # 63705507, 00585003017, articular surface, lot # 64084673, 00585205014, fluted stem extension, lot # 64178369, 00585204030, stem collar, lot # 64010286, 00598801014, stem extension straight, lot # 64244975.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2019 - 01437, 0001822565 - 2019 - 01438, 0001822565 - 2020 - 00089, 0001822565 - 2020 - 00091, 0001822565 - 2020 - 00092.
Event or Problem Description
It was reported that the patient underwent knee revision due to a periprosthetic distal femoral fracture.During the surgery, the surgeon became aware that the hospital did not have the correct cement to implant the devices.The surgeon implanted the patient without cement.Subsequently, the patient was brought back into surgery 4 hours later when the surgeon correctly implanted the devices.

• Brand Name: TIBIAL COMPONENT PRECOAT SIZE 6
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9558604
• Report Number: 0001822565-2020-00090
• Device Sequence Number: 19549629
• Product Code: KRO
• UDI-Device Identifier: 00889024199064
• UDI-Public: (01)00889024199064
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K013385
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/07/2020

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: 04/30/2022
• Device Model Number: N/A
• Device Catalogue Number: 00588000600
• Device Lot Number: 63631898
• 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: 01/06/2020
• Initial Report FDA Received Date: 01/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention