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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR FEM COMP #5 L-CEM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

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STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR FEM COMP #5 L-CEM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 5510F501
Device Problems Material Too Rigid or Stiff (1544); Failure to Align (2522); Insufficient Information (3190)
Patient Problems Injury (2348); No Code Available (3191)
Event Date 11/20/2015
Event Type  Injury  
Manufacturer Narrative

An evaluation of the device cannot be performed as the device and additional information were not made available to the manufacturer due to hospital policy. Should additional information become available it will be reported in a supplemental report upon completion of the investigation. Not returned to the manufacturer.

 
Event Description

Patient left knee was revised for stiffness and malalignment.

 
Manufacturer Narrative

An event regarding stiffness and malalignment involving a triathlon femoral component was reported. The event was not confirmed. Method & results: device evaluation and results: not performed as product was not returned. Medical records received and evaluation: not performed as no medical records were provided. Device history review: the device was manufactured and accepted into final stock with no reported discrepancies. Complaint history review: there have been no other similar reported events for the lot referenced. Conclusion: the exact cause of the event could not be determined as insufficient information was provided. Further information such as device return, x-rays and operative reports as well as patient history and follow-up notes are needed to complete the investigation for determining a root cause. No further investigation is possible at this time. If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

 
Event Description

Patient left knee was revised for stiffness and malalignment.

 
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Brand NameTRIATHLON CR FEM COMP #5 L-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
beverly lima
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key5307279
MDR Text Key33788241
Report Number0002249697-2015-04284
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 11/20/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/17/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date11/30/2019
Device Catalogue Number5510F501
Device LOT NumberEL83P
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 Received01/19/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/01/2014
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: 12/17/2015 Patient Sequence Number: 1
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