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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #5 11MM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

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STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #5 11MM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 5531G511
Device Problems Difficult To Position (1467); Insufficient Information (3190)
Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)
Event Date 09/13/2016
Event Type  Malfunction  
Manufacturer Narrative

An evaluation of the device cannot be performed as the device was 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. Not returned to the manufacturer.

 
Event Description

Per technical service rep, the liner did not seat.

 
Manufacturer Narrative

An event regarding a seating/locking issue involving a triathlon insert was reported. The event was not confirmed. Method & results: -device evaluation and results: not performed as the device was not returned for evaluation. -medical records received and evaluation: not performed as no medical records were provided. -device history review: indicates devices were manufactured and accepted into final stock with no reported discrepancies. -complaint history review: chr review for the reported lot confirmed that there are no other similar events reported. Conclusions: the exact cause of the event could not be determined because the devices were not returned for evaluation and no medical information was provided. If the devices and/or additional information are received, this investigation will be reopened and re-evaluated. 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

Per technical service rep, the liner did not seat.

 
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Brand NameX3 TRIATHLON CS INSERT #5 11MM
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 Key6013544
MDR Text Key57360830
Report Number0002249697-2016-03197
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 09/13/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/10/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number5531G511
Device LOT NumberLFC161
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 Received11/11/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/18/2016
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: 10/10/2016 Patient Sequence Number: 1
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