MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIMPLEX P-JAPANESE TWIN PACK; BONE CEMENT

Catalog Number 61910002

Device Problem Insufficient Information (3190)

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

Event Date 11/08/2019

Event Type  Death  

Manufacturer Narrative

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.Device not returned.

Event Description

A (b)(6) year-old female patient underwent a bha.Following the cement and exeter insertion, her blood pressure gradually decreased.Then, she went into cardiac arrest for which cardiopulmonary resuscitation was performed.But she died eventually on the same day.According to the surgeon she had a cardiac surgery before and it was probable that her heart could not tolerate drop in blood pressure.

Event Description

A 75-year-old female patient underwent a bha.Following the cement and exeter insertion, her blood pressure gradually decreased.Then, she went into cardiac arrest for which cardiopulmonary resuscitation was performed.But she died eventually on the same day.According to the surgeon she had a cardiac surgery before and it was probable that her heart could not tolerate drop in blood pressure.

Manufacturer Narrative

Correction: corrected lot # and type of reportable event 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 twin 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.

• Brand Name: SIMPLEX P-JAPANESE TWIN PACK
• Type of Device: BONE CEMENT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9430305
• MDR Text Key: 184883363
• Report Number: 0002249697-2019-03965
• Device Sequence Number: 1
• Product Code: LOD
• 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: 01/03/2020

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: 04/30/2022
• Device Catalogue Number: 61910002
• Device Lot Number: JHY021
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/08/2019
• Initial Date FDA Received: 12/06/2019
• Supplement Dates Manufacturer Received: 12/05/2019
• Supplement Dates FDA Received: 01/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 75 YR