MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIMPLEX P FULL DOSE 1 PACK; BONE CEMENT

Catalog Number	6191-1-001
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
As reported via medsun (b)(4): bone cement was opened to the field.All prep was completed correctly by the surgical tech.Surgeon noticed bone cement was hardening rapidly.Typically, the bone cement doesn't harden as fast as it did in this case (simplex p hardened under 9 minutes).Due to the cement hardening faster than usual, it caused the case to go over time.Surgeon had to remove some of the cement to correctly place the implants.Surgeon stated, "the cement opened was a bad batch.".
Additional Manufacturer Narrative
Reported event: an event regarding setting time involving a simplex cement mix was reported.The event was not confirmed.Method & results: device evaluation and results: material analysis, visual, functional, and dimensional inspections could not be performed as the device was not returned.A visual inspection of a retained sample was performed while mixing the product.No visual characteristics were observed.Samples appeared to have a homogenous appearance.All results met specification.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate packs were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there has been other similar events for the reported lot.Conclusions: material analysis, visual, functional, and dimensional inspections could not be performed as the device was not returned.A visual inspection of a retained sample was performed while mixing the product.No visual characteristics were observed.Samples appeared to have a homogenous appearance.All results met specification.The ifu packaged with the device at the time of manufacture indicates instructions for mixing the cement as well as a setting time chart which provides a reasonable indication of the cement¿s mixing and handling characteristics for the particular operating room temperature.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
No new information.

• Brand Name: SIMPLEX P FULL DOSE 1 PACK
• Common Device Name: 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22336091
• Report Number: 0002249697-2025-00641
• Device Sequence Number: 18390864
• Product Code: LOD
• UDI-Device Identifier: 07613327128444
• UDI-Public: 07613327128444
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K062553
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 6191-1-001
• Device Lot Number: RKF279
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/02/2025
• Supplement Date Received by Manufacturer: 09/17/2025
• Initial Report FDA Received Date: 06/26/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/20/2024
• 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
• Patient Sex: Unknown