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

Catalog Number 61969010

Device Problem Difficult to Insert (1316)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/05/2019

Event Type  malfunction  

Manufacturer Narrative

Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

Event Description

During surgery the antibiotic simplex bone cement didn't stick to the acetabulum after vigorous effort.This made surgeon a bit annoyed.The prosthesis was coming out along with the cement mantel.He then scrap out the cement and asked to open new one i.E.Plain simplex but the same issue continued.He was very angry with such performance of simplex and asked to get palacos antibiotic cement.It took around 40 mins to get palacos to the ot and till then the surgery was on pause.Update: all cement was used.Nothing else was added to the cement.There was no water, saline, blood, fat, etc.Present that may have affected the setting time.The storage conditions (humidity/ temperature) of the product 12-24 hours prior to introduction into the operating room environment was ot temp 16 deg.The length time product was in the operating room environment prior to use was after opening of its package, it is used within a minute.The storage conditions (humidity/ temperature) during storage and is the humidity/ temperature regulated in this environment was ot temp 16-17 deg.The product was not stored in the refrigerator prior to use.The utensils/ bowl mixing system stored prior to the surgery were autoclaved and fully dried.The temperature the utensils/bowl mixing system stored at prior to use was ot temp.The operating room temperature was 16 deg.

Manufacturer Narrative

An event regarding setting time of the bone cement mix involving simplex abc (antibiotic 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.Device history review: indicated that all product was manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusions: the investigation concluded that the reported setting time issue cannot be duplicated.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 ifu.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

During surgery the antiboitic simplex bone cement didn't stick to the acetabulam after vigorous effort.This made surgeon a bit annoyed.The prosthesis was coming out along with the cement mantel.He then scrap out the cement and asked to open new one i.E.Plain simplex but the same issue continued.He was very angry with such performance of simplex and asked to get palacos antiboitic cement.It took around 40 mins to get palacos to the ot and till then the surgery was on pause.Update: all cement was used.Nothing else was added to the cement.There was no water, saline, blood, fat, etc.Present that may have affected the setting time.The storage conditions (humidity/ temperature) of the product 12-24 hours prior to introduction into the operating room.Environment was ot temp 16 deg.The length time product was in the operating room.Environment prior to use was after opening of its package, it is used within a minute.The storage conditions (humidity/ temperature) during storage and is the humidity/ temperature regulated in this environment was ot temp 16-17 deg.The product was not stored in the refrigerator prior to use.The utensils/ bowl mixing system stored prior to the surgery were autoclaved and fully dried.The temperature the utensils/bowl mixing system stored at prior to use was ot temp.The operating room temperature was 16 deg.

• Brand Name: SIMPLEX P - CE ABC FD 10-PK
• Type of Device: BONE CEMENT, ANTIBIOTIC
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8666340
• MDR Text Key: 148303046
• Report Number: 0002249697-2019-02158
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 08/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2018
• Device Catalogue Number: 61969010
• Device Lot Number: BAZ004
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other