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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER CEMENT BONE SIMPLEX
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STRYKER CEMENT BONE SIMPLEX Back to Search Results
Model Number 61911001
Device Problems Detachment Of Device Component (1104); Entrapment of Device (1212); Material Fragmentation (1261); Nonstandard Device (1420)
Patient Problems Bone Fracture(s) (1870); Bone Fracture(s) (1870); Headache (1880); Headache (1880); Pain (1994); Pain (1994); Discomfort (2330); Sleep Dysfunction (2517); Device Embedded In Tissue or Plaque (3165)
Event Date 03/30/2017
Event Type  Injury  
Event Description
Patient called to report problems with her stryker triathlon titanium knee replacement system.Patient stated that the day following her replacement surgery, she experienced extreme pain and suffering.The patient said after doing some research, she discovered that the bone cement used during her knee replacement surgery matched the model number that was recalled.The patient said she found out later that the doctor broke her tibia and put pegs in her leg during the replacement surgery, but the doctor had not told her.Patient stated the entire knee that was replaced is in unbearable pain and she experiences severe headaches as well.
 
Event Description
Add'l info received on 03/20/2018, for report number mw5075603.Caller reported an ultrasound was performed and device fragments were found lodged into her leg.Caller is continuing to experience pain, suffering, discomfort, and inability to sleep due to the device.
 
Event Description
Patient called to report problems with her stryker triathlon titanium knee replacement system.Patient stated that the day following her replacement surgery, she experienced extreme pain and suffering.The patient said after doing some research, she discovered that the bone cement used during her knee replacement surgery matched the model number that was recalled.The patient said she found out later that the doctor broke her tibia and put pegs in her leg during the replacement surgery, but the doctor had not told her.Patient stated the entire knee that was replaced is in unbearable pain and she experiences severe headaches as well.
 
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Brand Name
CEMENT BONE SIMPLEX
Type of Device
CEMENT BONE SIMPLEX
Manufacturer (Section D)
STRYKER
MDR Report Key7305677
MDR Text Key101503618
Report NumberMW5075603
Device Sequence Number0
Product Code MBB
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial,Followup
Report Date 02/28/2018
4 Devices were Involved in the Event: 1   2   3   4  
2 Patient was Involved in the Event
Date FDA Received02/28/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Model Number61911001
Is the Reporter a Health Professional? No
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number0
Patient Outcome(s) Other;
Patient Age59 YR
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