MAUDE Adverse Event Report: SMITH & NEPHEW, INC. VERSABOND 40 GRAM F2; BONE CEMENT

Model Number	71271340
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Arrhythmia (1721)
Date of Event	08/28/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that two minutes after the use of bone cement, the patient developed arrhythmias, frequent ventricular diurnal, and diurnal rhythm.
Additional Manufacturer Narrative
It was reported that two minutes after the use of bone cement, the patient developed arrhythmias, frequent ventricular diurnal, and diurnal rhythm.The affected versabond cement, used in treatment, was not returned for evaluation as it was used in the patient.A review of the manufacturing records by the manufacturer for the listed batch did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A relationship, if any, between the device and the adverse event could not be corroborated.A clinical analysis noted that per the operative report, the femoral cavity was cleaned by irrigation.However, the instructions for use recommends the site should be cleansed and aspirated prior to use of the bone cement.It is unknown if the ifu for mixing, pressurizing and careful monitoring of the patient¿s blood pressure during the application was followed as it further warns that cardiac arrhythmia can occur between 10 and 165 seconds after its application.Additionally, it was not specified if this patient was transfused simultaneously during the application of the versabond and/or whether patient¿s cormobidities cannot be ruled out as a contributing factor (possible cause) to this reported event.The surgeon stated: ¿after the emergency decompression of bone marrow cavity, the cardiac rhythm changed to sinus rhythm after 5 minutes and no adverse prognosis was found.¿ review of the risk management files identified the reported failure as potential adverse events.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: VERSABOND 40 GRAM F2
• Common Device Name: BONE CEMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9151634
• Report Number: 1020279-2019-03548
• Device Sequence Number: 14105143
• Product Code: LOD
• UDI-Device Identifier: 03596010494726
• UDI-Public: 03596010494726
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K033509
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2020

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: 02/19/2021
• Device Model Number: 71271340
• Device Catalogue Number: 71271340
• Device Lot Number: 18BC01710
• Initial Date Received by Manufacturer: 09/05/2019
• Supplement Date Received by Manufacturer: 03/27/2020
• Initial Report FDA Received Date: 10/03/2019
• Supplement Report FDA Received Date: 04/03/2020
• 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: Required Intervention
• Patient Age: 67 YR