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

Catalog Number	71271340
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/02/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during intra-operative discarding of the self-locking prosthetic stem to the cement prosthetic interface.
Additional Manufacturer Narrative
A relationship, if any, between the subject bone cement and implant reported event could not be determined since product was not returned.Without supporting clinical/medical documents a thorough investigation cannot be performed.The complaint could not be verified, nor could a root cause be determined with confidence.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.This investigation could not verify or identify any evidence of product contribution to the reported problem.Based on this investigation, the need for corrective action is not indicated.If any product associated with this event is returned at a future date, the evaluation will be reopened for investigation.Our investigation including a review of complaint history for the listed product revealed no prior complaints for the listed failure mode with the same batch number.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Should clinical information become available, a clinical review will be conducted.No additional actions are being taken at this time; however we will continue to monitor for future complaints and investigate as necessary.Should additional event information be received, the 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: 8181288
• Report Number: 1020279-2018-02837
• Device Sequence Number: 1914863
• Product Code: LOD
• UDI-Device Identifier: 03596010494726
• UDI-Public: 03596010494726
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 04/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: 71271340
• Device Lot Number: 16LC01690
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/21/2018
• Supplement Date Received by Manufacturer: 11/21/2018
• Initial Report FDA Received Date: 12/19/2018
• Supplement Report FDA Received Date: 04/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1