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

Model Number	71271440
Medical Device Problem Code	Failure to Back-Up (1047)
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/01/1901
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a total knee arthroplasty surgeon complained about the flaky texture of the radiopaque bone cement.The second package opened gave the same result.In order to overcome this problem, the surgeons had to use synicem 1g bone cement.
Additional Manufacturer Narrative
Results of investigation: the devices, intended for use in treatment, were not returned for evaluation and the reported event could not be confirmed.A review of the manufacturing records for the provided batch did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.Although there were no prior complaints for one of the two reported devices.One device is reusable product that can be exposed to numerous surgeries; damage from repeated use can occur.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.Factors and/or some potential probable causes that could include but not limited exposure to improper temperature settings, mixing time, incorrect chemical composition, and shipped improperly.The supplier was made aware of the complaint.In addition, they have tested another retain sample of the referenced batch 18lc07540 at 21°c by hand mixing in a beaker with spatula.The sample shows a slightly sandy behavior until 1:30 minutes after begin of mixing, but got its usual texture after total 2 minutes; handling times as defined in the handling charts of the ifu have been confirmed.We recommend that all reusable product be routinely inspected for wear and damage and replaced as necessary.

• Brand Name: VERSABOND AB 40 GRAMS F2
• Common Device Name: BONE CEMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: sarah freestone ; 1450 brooks road
• MDR Report Key: 9869676
• Report Number: 1020279-2020-00988
• Device Sequence Number: 3041211
• Product Code: LOD
• UDI-Device Identifier: 03596010507372
• UDI-Public: 03596010507372
• Combination Product (Y/N): N
• PMA/510(K) Number: K022688
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/27/2022

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
• Device Expiration Date: 11/22/2021
• Device Model Number: 71271440
• Device Catalogue Number: 71271440
• Device Lot Number: 18LC07540
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 02/29/2020
• Supplement Date Received by Manufacturer: 10/29/2020; 01/08/2021; 09/27/2022
• Initial Report FDA Received Date: 03/23/2020
• Supplement Report FDA Received Date: 11/04/2020; 01/11/2021; 09/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0933-2021
• Patient Sequence Number: 1
• Patient Sex: Unknown