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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR X3 TIBIAL INSERT PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

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STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR X3 TIBIAL INSERT PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 5530-G-409
Device Problems Break (1069); No Apparent Adverse Event (3189)
Patient Problems Fall (1848); No Consequences Or Impact To Patient (2199)
Event Date 11/20/2015
Event Type  Injury  
Manufacturer Narrative

An evaluation of the device cannot be performed as the device was discarded and was not returned to the manufacturer. 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

Complete disruption of the right distal quadricep. Patient fell last week. The patient was revised.

 
Manufacturer Narrative

An event regarding a revision surgery after a patient fall involving a triathlon insert was reported. Method & results: -device evaluation and results: could not be performed as no items associated with the event were returned or made available for identification or evaluation. -medical records received and evaluation: no medical records or x-rays were made available for evaluation. -device history review: review of the device history records indicates that all devices were manufactured and accepted into final stock with no reported discrepancies. -complaint history review: not performed as the reason for revision is unknown. Conclusions: the event could not be confirmed nor the root cause of the reported event determined due to the minimal information received. There is no indication at this time that the design, materials, or manufacturing of the subject device contributed to the event. 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

Complete disruption of the right distal quadricep. Patient fell last week. The patient was revised.

 
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Brand NameTRIATHLON CR X3 TIBIAL INSERT
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
beverly lima
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key5307268
MDR Text Key33788570
Report Number0002249697-2015-04275
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeAU
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 Date04/30/2020
Device Catalogue Number5530-G-409
Device LOT NumberE68RVJ
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 Received01/07/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/28/2015
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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