MAUDE Adverse Event Report: SYNTHES USA VERTECEM V+ CEMENT KIT; POLYMETHYLMETHACRYLATE BONE CEMENT

Catalog Number 07.702.016S

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Embolism (1829)

Event Type  Injury  

Manufacturer Narrative

Patient information is not available for reporting.It is unknown how many patients were involved.(b)(4).Vertecem v+ cement kit includes implant and instrument.Instrument device was not implanted/explanted.It is unknown when the implant procedure occurred and if the implants were explanted.Device is not expected to be returned for manufacturer review/investigation.(b)(6).Device is not distributed in the united states, but is similar to device marketed in the usa.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Device history records review could not be completed without lot number.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes europe reports an event in (b)(6) as follow: it was reported that when using vertecem v+ cement an embolism to the vena cava or up in the pulmonary arteries occurred.Cement embolism in more than one patient was reported.It is unknown how many patients were involved and what the patient outcomes are.This report is for one (1) vertecem v+ cement kit.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

A product investigation was completed: based on the complaint description, without material and without knowing the lot number no investigation or disposition is possible.Since no parts were received at investigation site and the complaint description is unspecific, it could not be confirmed that the complaint event was design driven.The review of the complaint file led to the conclusion that the complaint was caused by an inappropriate injection technique.The resulting harm has been identified as embolism caused by leakage of bone cement into the blood stream.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that when the surgeon was evaluating cement augmentations with post-operative ct on unknown dates, he identified cement embolism in the vena cava/pulmonary arteries.The surgeon tried to improve the application regime in various ways without success.

• Brand Name: VERTECEM V+ CEMENT KIT
• Type of Device: POLYMETHYLMETHACRYLATE BONE CEMENT
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6323563
• MDR Text Key: 67165571
• Report Number: 2520274-2017-10451
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07.702.016S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention