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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRITANIUM BPLATE TRIATHLON S6 PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

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STRYKER ORTHOPAEDICS-MAHWAH TRITANIUM BPLATE TRIATHLON S6 PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 5536B600
Device Problems Plate (907); Collapse (1099); Osseointegration Problem (3003)
Patient Problem Pain (1994)
Event Date 08/23/2016
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. Not returned to the manufacturer.

 
Event Description

Patient had a painful knee and x-ray revealed a collapsed tibial baseplate.

 
Manufacturer Narrative

An event regarding tibial loosening involving a tritanium baseplate was reported. The event was confirmed. Method & results: device evaluation and results: one photograph of the explanted devices was attached. The baseplate appears to have tissue attached. The insert appears unremarkable. Medical records received and evaluation: the tritanium baseplate is grossly loose and has dropped into varus position with lateral bone lift-off. Posterior tibial slope appears still adequate. Original tibial baseplate position cannot be evaluated due to gross change in position after loosening. Available post event x-rays document gross baseplate loosening with varus dislocation and lateral bone lift-off. The explant photograph shows only adherent fibrous tissue as sign of fixation failure through lack of bone ingrowth. The poly bearing shows no obvious pathology. 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 events for the lot referenced. Conclusions: medical review confirms baseplate loosening however the exact root cause could not be determined because insufficient medical information was provided. Further information such as product return, early post implantation x-rays, operative notes, patient history and follow-up notes are needed to complete the investigation for determining a root cause. A capa trend analysis was conducted for the reported failure mode and concluded tritanium baseplate loosening may result from factors not related to the device. No further investigation for this event is possible at this time as insufficient information was received by stryker orthopaedics. If additional information becomes available, this investigation will be reopened.

 
Event Description

Patient had a painful knee and x-ray revealed a collapsed tibial baseplate.

 
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Brand NameTRITANIUM BPLATE TRIATHLON S6
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 Key5959122
MDR Text Key55000218
Report Number0002249697-2016-02969
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 08/23/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/18/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number5536B600
Device LOT NumberCTD9957
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 Received10/21/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/29/2016
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: 09/18/2016 Patient Sequence Number: 1
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