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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH NO 4. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 13MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

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STRYKER ORTHOPAEDICS-MAHWAH NO 4. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 13MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL Back to Search Results
Catalog Number 5537-G-413
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problems Tissue Damage (2104); Rupture (2208); Injury (2348)
Event Date 05/27/2016
Event Type  Injury  
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.

 
Event Description

Poly exchange due to soft tissue rupture.

 
Manufacturer Narrative

An event regarding revision due to patient factors (soft tissue rupture) involving a triathlon insert was reported. The event was not confirmed. Method & results: -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. Conclusions: 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.

 
Event Description

Poly exchange due to soft tissue rupture.

 
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Brand NameNO 4. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 13MM
Type of DevicePROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
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
keyla colon
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key5745834
MDR Text Key48063061
Report Number0002249697-2016-02031
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 01/25/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/23/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number5537-G-413
Device LOT Number4J1DEN
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 Received12/28/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/02/2016
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: 06/23/2016 Patient Sequence Number: 1
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