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	Low Blood Pressure/ Hypotension (1914)
Date of Event	10/23/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during an unspecified surgery, the patient had a transient allergic reaction for about 4 min after versabond was injected.It was noticed by a decrease in the blood pressure.The event was resolved after medication.The patient was not harmed beyond the stated event.
Additional Manufacturer Narrative
It was reported that during an unspecified surgery, the patient had a transient allergic reaction for about 4 min after versabond was injected.The associated device, used in treatment, was not returned for evaluation.Thus the product analysis could not be performed.A review of manufacturing records did not reveal any deviation from the standard manufacturing processes.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.A relationship, if any, between the device and the reported incident could not be corroborated.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.The instructions for use and risk management files were reviewed and the ifu identifies the reported issue in the warnings section.Some potential causes could include but are not limited to patient reaction or patient allergy.It was reported that the event was resolved with medication.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however, smith and nephew will continue to monitor for future complaints and investigate as necessary.Should additional information be received, this complaint will be reopened and reevaluated.

• 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: 10046580
• Report Number: 1020279-2020-01603
• Device Sequence Number: 16983556
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2020

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
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/14/2020
• Supplement Date Received by Manufacturer: 06/17/2020
• Initial Report FDA Received Date: 05/12/2020
• Supplement Report FDA Received Date: 06/20/2020
• 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