MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIMPLEX P - CE TOBRA FD 10-PK; BONE CEMENT

Catalog Number 61971010

Device Problems Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Injury (2348); No Known Impact Or Consequence To Patient (2692)

Event Date 01/31/2016

Event Type  malfunction  

Manufacturer Narrative

Additional information has been requested.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

Event Description

The customer reported that the simplex cement set much more quickly than expected.The customer further reported that the cement had been placed into the patients' femur and that this had set before the surgeon has chance to implant the stem.The surgeon had to undertake a cement in cement revision to complete the case.The customer is an experienced user of this cement and have been using this for some years.The customer reported that there had been no changes to the way the cement was mixed or stored.

Manufacturer Narrative

An event regarding setting time involving simplex with tobramycin bone cement was reported.The event was not confirmed.Method & results: device evaluation and results: visual inspection and functional testing was completed on the three retained samples tested from the reported lot.The results were satisfactory and within specification.Medical records received and evaluation: not performed as no medical records were provided.It was reported that during surgery the cement had set before the stem was implanted.The surgeon had to remove the cement to complete the surgery however the length of the surgical delay was not provided.Device history review: bmr review for the specified lot indicates that the devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been two other events for the lot referenced.These two other events are in relation to the same surgeon.Trend request # 809 has been submitted.Conclusions: the investigation concluded that the reported setting time issue cannot be confirmed.The mixing properties of the retained samples of the reported lot code were tested and show that all required specifications are met.The mixing characteristics and working properties of surgical simplex bone cements are influenced primarily by the temperature of the liquid and powder components at the time of mixing and by the temperatures of the utensils with which it contacts during mixing e.G.Mixing bowls, cement introducers etc.Generally, higher temperatures accelerate the polymerization reaction and lower temperatures delay it.Other factors which can affect setting time are mixing technique (speed, use of vacuum, centrifugation), thoroughness of mixing, complete utilization of all of the powder & liquid and care to avoid inclusion of any extraneous material such as blood or sterilization solutions into the mix.Mixing process/technique issues are highlighted in the or handbook.Based on the laboratory results of the retain samples it is not possible to replicate this event.No further investigation for this event is possible at this time.If additional information becomes available this investigation will be reopened.

Event Description

The customer reported that the simplex cement set much more quickly than expected.The customer further reported that the cement had been placed into the patients' femur and that this had set before the surgeon has chance to implant the stem.The surgeon had to undertake a cement in cement revision to complete the case.The customer is an experienced user of this cement and have been using this for some years.The customer reported that there had been no changes to the way the cement was mixed or stored.

• Brand Name: SIMPLEX P - CE TOBRA FD 10-PK
• Type of Device: BONE CEMENT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA
• Manufacturer Contact: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5461456
• MDR Text Key: 39433902
• Report Number: 0002249697-2016-00567
• Device Sequence Number: 1
• Product Code: LOD
• Combination Product (y/n): N
• Reporter Country Code: GB
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Catalogue Number: 61971010
• Device Lot Number: TGW044
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/21/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/06/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other