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

Catalog Number 61910002

Device Problems Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problem Pulmonary Embolism (1498)

Event Date 02/19/2021

Event Type  Death  

Manufacturer Narrative

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

Information from competitor.Competitor system and simplex was used.Patient who underwent artificial elbow joint surgery died of pulmonary embolus after surgery.During surgery, the humerus was plugged and the bone cement was injected with the competitor cement system, but on the image, it was confirmed that the cement restrictor moved and the bone cement leaked to the proximal humerus.The ulna was plugged and bone cement was manually injected.

Manufacturer Narrative

Reported event: an event regarding patient factors involving a simplex cement mix was reported.The event was not confirmed.Method & results -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remained implanted.-medical records received and evaluation: no medical records were received for review with a clinical consultant -product history review: could not be performed as lot code information was not provided.-complaint history review: could not be performed as lot code information was not provided.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as postmortem report, return of the device, pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.

Event Description

Information from competitor.Competitor system and simplex was used.Patient who underwent artificial elbow joint surgery died of pulmonary embolus after surgery.During surgery, the humerus was plugged and the bone cement was injected with the competitor cement system, but on the image, it was confirmed that the cement restrictor moved and the bone cement leaked to the proximal humerus.The ulna was plugged and bone cement was manually injected.On (b)(6), 2021, we confirmed that sales rep did not obtain any information from the facility.

• Brand Name: SIMPLEX P-JAPANESE TWIN 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 ; EI NA
• Manufacturer Contact: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 11969693
• MDR Text Key: 255233107
• Report Number: 0002249697-2021-00998
• Device Sequence Number: 1
• Product Code: LOD
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/14/2021

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 Catalogue Number: 61910002
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/18/2021
• Initial Date FDA Received: 06/09/2021
• Supplement Dates Manufacturer Received: 11/18/2021
• Supplement Dates FDA Received: 12/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Death
• Patient Sex: Female