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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS FEM COMP #2L-CEM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

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STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS FEM COMP #2L-CEM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 5515F201
Device Problems Failure To Adhere Or Bond (1031); Insufficient Information (3190)
Patient Problems Pain (1994); Injury (2348)
Event Date 11/10/2015
Event Type  Injury  
Manufacturer Narrative
It was noted that the device is not available for evaluation. Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation. Not available.
 
Event Description
Per sales rep, the doctor said the patient was having pain. He had a bone scan done. The scan was lighting up showing signs for possible loosening of both femoral and tibial components. He did a revision total knee this morning.
 
Manufacturer Narrative
An event regarding loosening involving a triathlon femoral component was reported. The event was not confirmed. Method & results: device evaluation and results: not performed as the device was not returned. Medical records received and evaluation: not performed as no medical records were provided. Device history review: indicated devices were manufactured and accepted into final stock on with no reported discrepancies. Complaint history review: chr confirmed that there have been no other similar events for the reported lot. Conclusion: the exact cause of the event could not be determined because insufficient information was provided. Further information such as device return, operative reports, x-rays, patient history and follow-up notes are needed to investigate this event further. If additional information and/or device become available, this investigation will be reopened.
 
Event Description
Per sales rep, the doctor said the patient was having pain. He had a bone scan done. The scan was lighting up showing signs for possible loosening of both femoral and tibial components. He did a revision total knee this morning.
 
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Brand NameTRIATHLON PS FEM COMP #2L-CEM
Type of DevicePROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-LIMERICK
raheen business park
limerick NA
Manufacturer Contact
keyla colon
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key6070025
MDR Text Key58916444
Report Number0002249697-2016-03436
Device Sequence Number1
Product Code MBH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K141056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/04/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/01/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/31/2016
Device Catalogue Number5515F201
Device Lot NumberS377N
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/07/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/03/2011
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/01/2016 Patient Sequence Number: 1
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