MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIMPLEX P WITH TOBRAMYCIN 1 PACK; BONE CEMENT

Catalog Number 6197-9-001

Device Problem Positioning Failure (1158)

Patient Problem No Code Available (3191)

Event Date 04/08/2015

Event Type  malfunction  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer.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

User facility report number (b)(4) stated: bone graft was harvested from the humeral head.Surgeon mixed a gram of vancomycin per batch and methylene blue in the cement.The cement was impacted.Bone graft was placed on top of the cement and as i was implanting the humeral component, the implant was not passing and it became evident the cement was hardening prematurely.Surgeon removed the implant quickly and unfortunately the cement had already hardened.This was less than 4 minutes after mixing the cement.Surgeon proceeded to remove the cement from the canal.Using an osteotome and a drill bit, i removed the cement down to the distal portion.I then drilled past the cement and placed a guidewire and drilled with a 5 - 5 reamer and then ultimately was able to place a ball tip guidewire, 8.5 reamer and passed through the cement.I brought on a size 6 implant onto the field.This provided a better fit given the cement distally.The canal was irrigated copiously.New cement was mixed with again a gram of vancomycin in the batch.The cement was impacted, the implant was placed in 30 degrees of retroversion and held in position while the cement hardened.Delay of case by 1 hour.The second batch of cement from the same lot was used without any issues.Cure time (hardening) expected as from 7 to 10-12 minutes.

Manufacturer Narrative

An event regarding setting time involving simplex bone cement was reported.The event was not confirmed.Method & results: device evaluation and results: visual inspection and functional testing was completed on three retain samples of the reported lot.The results were satisfactory and within specification.Medical records received and evaluation: not performed as no medical records were received.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: chr review determined that there were no other similar events reported for the referenced lot.Conclusions: the investigation concluded that the reported setting time issue cannot be confirmed.The mixing properties of the retain samples of the reported lot code were tested and show that all required specifications are met.The mixing characteristics and working properties of 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.It is noted that the surgeon mixed a gram of vancomycin per batch and methylene blue in the cement.Based on the laboratory results of the retain samples it is not possible to replicate this event.A capa trend analysis was conducted for the reported failure mode and concluded that simplex setting time issues may result from other factors not necessarily related to the product.No further investigation for this event is possible at this time.If additional information becomes available this investigation will be reopened.

Event Description

User facility report number (b)(4) stated: bone graft was harvested from the humeral head.Surgeon mixed a gram of vancomycin per batch and methylene blue in the cement.The cement was impacted.Bone graft was placed on top of the cement and as i was implanting the humeral component, the implant was not passing and it became evident the cement was hardening prematurely.Surgeon removed the implant quickly and unfortunately the cement had already hardened.This was less than 4 minutes after mixing the cement.Surgeon proceeded to remove the cement from the canal.Using an osteotome and a drill bit, i removed the cement down to the distal portion.I then drilled past the cement and placed a guidewire and drilled with a 5 - 5 reamer and then ultimately was able to place a ball tip guidewire, 8.5 reamer and passed through the cement.I brought on a size 6 implant onto the field.This provided a better fit given the cement distally.The canal was irrigated copiously.New cement was mixed with again a gram of vancomycin in the batch.The cement was impacted, the implant was placed in 30 degrees of retroversion and held in position while the cement hardened.Delay of case by 1 hour.The second batch of cement from the same lot was used without any issues.Cure time (hardening) expected as from 7 to 10-12 minutes.

• Brand Name: SIMPLEX P WITH TOBRAMYCIN 1 PACK
• 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 navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5216482
• MDR Text Key: 31210159
• Report Number: 0002249697-2015-03701
• Device Sequence Number: 1
• Product Code: LOD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K014199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2015
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2017
• Device Catalogue Number: 6197-9-001
• Device Lot Number: RHV086
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2014
• 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
• Patient Age: 60 YR