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

Catalog Number	6191-1-001
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following devices were also listed in this report: simplex p with tobramycin 1 pack; cat # 6197-9-001; lot # mhu072 it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Reported event: an event regarding pain 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 has been no other similar event for the lot referenced.Conclusions: it was reported that the patient is experiencing pain.The exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports, pre- and post-operative x-rays 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 become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
As reported via mw5159967: clicking noise, hurts when laying down.Device location: left.(note: stryker cement used with competitor implants).

• 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20667164
• Report Number: 0002249697-2024-01544
• Device Sequence Number: 12887350
• Product Code: LOD
• UDI-Device Identifier: 07613327128444
• UDI-Public: 07613327128444
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K062553
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/12/2024

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: 05/31/2016
• Device Catalogue Number: 6191-1-001
• Device Lot Number: RHU127
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/23/2024
• Initial Report FDA Received Date: 11/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/27/2013
• 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: Other
• Patient Sex: Unknown