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

Catalog Number	6197-9-001
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Bone Cement Implantation Syndrome (4583)
Date of Event	08/06/2024
Type of Reportable Event	Death
Additional 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.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.
Event or Problem Description
Bha was performed for right femoral neck fracture.Two minutes after filling the intrathecal cavity with cement and inserting the stem, the oxygen saturation level began to gradually decrease, followed by a drop in blood pressure and the patient went into cardiac arrest.The patient was confirmed dead on the same day.
Additional Manufacturer Narrative
Corrected data: complaint history review (h11).An event regarding bone cement implantation syndrome (bcis) involving 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: review of the device history records indicate ten-packs were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been 1 other similar events for the lot referenced, which relates to the same patient/device therefore no further trending is required.Conclusions: it was reported that two minutes after filling the intrathecal cavity with cement and inserting the stem, the oxygen saturation level began to gradually decrease, followed by a drop in blood pressure and the patient went into cardiac arrest.The patient was confirmed dead on the same day.The exact cause of the event could not be determined because insufficient information was provided.Further information such as the 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 additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Bha was performed for right femoral neck fracture.Two minutes after filling the intrathecal cavity with cement and inserting the stem, the oxygen saturation level began to gradually decrease, followed by a drop in blood pressure and the patient went into cardiac arrest.The patient was confirmed dead on the same day.

• Brand Name: SIMPLEX P WITH TOBRAMYCIN 1 PACK
• Common Device Name: 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: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20125531
• Report Number: 0002249697-2024-01196
• Device Sequence Number: 7417770
• Product Code: MBB
• UDI-Device Identifier: 07613327128420
• UDI-Public: 07613327128420
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K014199
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2025
• Device Catalogue Number: 6197-9-001
• Device Lot Number: MGE066
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/06/2024
• Supplement Date Received by Manufacturer: 11/20/2024
• Initial Report FDA Received Date: 09/03/2024
• Supplement Report FDA Received Date: 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/17/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 86 YR
• Patient Sex: Female
• Patient Weight: 65 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian