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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM CEM FXD BPLT #5 PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

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STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM CEM FXD BPLT #5 PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 5520B500
Device Problems Failure To Adhere Or Bond (1031); Insufficient Information (3190)
Patient Problems Pain (1994); Injury (2348)
Event Date 11/21/2016
Event Type  Injury  
Manufacturer Narrative

An evaluation of the device cannot be performed as the device was disposed of and not returned to the manufacturer. Additional information has been requested. Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

 
Event Description

Patient total knee revision due to lucency and pain.

 
Manufacturer Narrative

An event regarding loosening involving a triathlon baseplate was reported. The event was not confirmed. Method and results: device evaluation and results: not performed as the product was not returned. Medical records received and evaluation: not performed as no medical records were provided. Device history review: indicated the device was manufactured and accepted into final stock with no reported discrepancies. Complaint history review: indicated that there have been no other similar reported events for the lot referenced. Conclusions: the exact cause of the reported loosening could not be determined with the limited information provided. Further information such as product return, x-rays, operative notes, medical records and follow-up notes are needed to complete the investigation to determine a root cause. No further investigation for this event is possible at this time as no devices and insufficient information was received by stryker orthopaedics. If devices and / or additional information become available, this investigation will be reopened.

 
Event Description

Patient total knee revision due to lucency and pain.

 
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Brand NameTRIATHLON PRIM CEM FXD BPLT #5
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
cindy chuhinko
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key6185966
MDR Text Key62746665
Report Number0002249697-2016-03947
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK141056
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 02/17/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/19/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/30/2011
Device Catalogue Number5520B500
Device LOT NumberSBC8B
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 Received01/22/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/15/2006
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: 12/19/2016 Patient Sequence Number: 1
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