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

Model Number 6197-9-001

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

Patient Problem Cardiac Arrest (1762)

Event Date 12/13/2022

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Device not returned.

Event Description

Blood pressure decreased.Cardiac arrest should not have occurred.

Event Description

It was reported that: blood pressure decreased.Cardiac arrest should not have occurred.Update from the sales rep: "the patient did not die at the time the surgery was completed.Postoperative photos were reviewed and showed that the cement plug had been dislodged and cement had leaked into the medullary cavity.".

Manufacturer Narrative

An event regarding bcis 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 remains implanted.-clinician review: no medical records were received for review with a clinical consultant.-product history review: could not be performed as the device lot details were not provided.-complaint history review: could not be performed as the device lot details were not provided.Conclusions: it was reported that the patient's blood pressure dropped during surgery due to leakage of cement into the medullary cavity.Cardiac arrest was also reported, although it is unclear how it was addressed aside from stopping surgery before all devices were implanted.The exact cause of the event could not be determined because insufficient information was provided.Further information such as 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.

• Brand Name: SIMPLEX P WITH TOBRAMYCIN 1 PACK
• Type of Device: BONE CEMENT, ANTIBIOTIC
• 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: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16100770
• MDR Text Key: 306680785
• Report Number: 0002249697-2023-00013
• Device Sequence Number: 1
• Product Code: MBB
• UDI-Device Identifier: 07613327128420
• UDI-Public: 07613327128420
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 6197-9-001
• Device Catalogue Number: 6197-9-001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/21/2023
• 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): Other; Required Intervention; Hospitalization
• Patient Age: 60 YR
• Patient Sex: Female