MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SURGICAL SIMPLEX CEMENT; BONE CEMENT

Catalog Number 61910001

Device Problem Insufficient Information (3190)

Patient Problems Cardiac Arrest (1762); Death (1802)

Event Date 08/17/2019

Event Type  Death  

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

It has been reported from aemps (ministry of health of (b)(6): after the cementation of the prosthesis, a drop in etco2, ta and sao2 is detected, and resuscitation maneuvers are initiated immediately (administration of adrenaline, channeling of the arterial and central venous lines), requiring cardiac massage.After recovering ta and sinus rhythm, the patient is moved to urpa intubated ot with norepinephrine perfusion.During the transfer the patient presented bradycardia and subsequent asystole.After 90 minutes with no response to the administration of adrenaline boluses, the decision was taken not to continue the resuscitation maneuvers.

Manufacturer Narrative

Patient gender, age and 510k added.An event regarding patient death involving simplex p bone cement was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as no product was returned, the device remains implanted.Medical records received and evaluation: not performed as no medical records were provided.Device history review: indicated that all 10 packs were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: the exact cause of the event could not be determined as insufficient information was provided.Further information such as medical records, operative reports, full patient history as well as follow up notes are needed to complete the investigation for determining a root cause.No further investigation for this event is possible at this time as insufficient information was received.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

It has been reported from aemps (ministry of health of spain): after the cementation of the prosthesis, a drop in etco2, ta and sao2 is detected, and resuscitation maneuvers are initiated immediately (administration of adrenaline, channeling of the arterial and central venous lines), requiring cardiac massage.After recovering ta and sinus rhythm, the patient is moved to urpa intubated ot with norepinephrine perfusion.During the transfer the patient presented bradycardia and subsequent asystole.After 90 minutes with no response to the administration of adrenaline boluses, the decision was taken not to continue the resuscitation maneuvers.

• Brand Name: SURGICAL SIMPLEX CEMENT
• Type of Device: BONE CEMENT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9255051
• MDR Text Key: 164262630
• Report Number: 0002249697-2019-03641
• Device Sequence Number: 1
• Product Code: LOD
• Combination Product (y/n): N
• PMA/PMN Number: K062553
• 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: 12/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Catalogue Number: 61910001
• Device Lot Number: CFZ083
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/02/2019
• Initial Date FDA Received: 10/30/2019
• Supplement Dates Manufacturer Received: 12/02/2019
• Supplement Dates FDA Received: 12/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 92 YR