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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM TIB BASEPLATE - CEMENTED PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

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STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM TIB BASEPLATE - CEMENTED PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 5520-B-300
Device Problems Failure To Adhere Or Bond (1031); Insufficient Information (3190)
Patient Problems Injury (2348); No Code Available (3191)
Event Date 10/10/2016
Event Type  Injury  
Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer due to hospital policy. 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

Aseptic loosening of tibial baseplate of a left tka, cultures and specimens were negative from microbes. Removed poly and tibial baseplate, prepped for universal baseplate with stem and stem extender, inserted new baseplate stem and tibial insert.

 
Manufacturer Narrative

An event regarding loosening involving a triathlon baseplate was reported. The event was not confirmed. Device evaluation and results: a visual, functional and dimensional inspection could not be performed as the device was not returned. Medical records received and evaluation: no medical records or x-rays were made available for evaluation. Device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies complaint history review: there has been no other event for the lot referenced. The event could not be confirmed nor could the root cause be determined because the insufficient medical information was provided. Further information such as return of device, patient history, histopathology report & follow-up notes are needed to investigate this event further. If additional information and/or device becomes available, this investigation will be reopened. A capa trend analysis was conducted for the reported failure mode and concluded that loosening may result from other factors not necessarily related to the device.

 
Event Description

Aseptic loosening of tibial baseplate of a left tka, cultures and specimens were negative from microbes. Removed poly and tibial baseplate, prepped for universal baseplate with stem and stem extender, inserted new baseplate stem and tibial insert.

 
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Brand NameTRIATHLON PRIM TIB BASEPLATE - CEMENTED
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-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer Contact
joann lavatelli
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key6087105
MDR Text Key59409668
Report Number0002249697-2016-03490
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 01/18/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/08/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/31/2015
Device Catalogue Number5520-B-300
Device LOT NumberBLJK
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 Received12/20/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/21/2010
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: 11/08/2016 Patient Sequence Number: 1
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