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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS X3 TIBIAL INSERT IMPLANT

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STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS X3 TIBIAL INSERT IMPLANT Back to Search Results
Catalog Number 5532-G-611
Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)
Patient Problems Rupture (2208); Injury (2348)
Event Date 07/17/2015
Event Type  Injury  
Manufacturer Narrative

An evaluation of the device cannot be performed as the device was sent to (b)(4) and was not returned to the manufacturer. Additional information has not been made available due to hospital policy. 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

As per sales rep, patient had a revision due to quadricep tendon rupture. Surgeon decided to exchange liner.

 
Manufacturer Narrative

An event regarding revision involving a triathlon insert was reported. The event was not confirmed. Method & results: device evaluation could not be performed as the subject device was not returned. Medical records received and evaluation: not performed as no medical records were received for review. Device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies. Complaint history review: a complaint history review was not performed as no device specific failure modes were identified. Conclusions: the event could not be confirmed nor the root cause of the reported revision surgery determined due to the minimal information received. The clinical indication for the revision was not provided. No further investigation for this event is possible at this time as no devices and insufficient information was received by stryker orthopaedics. If devices and / or additional information become available, this investigation will be reopened.

 
Event Description

As per sales rep, patient had a revision due to quadricep tendon rupture. Surgeon decided to exchange liner.

 
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Brand NameTRIATHLON PS X3 TIBIAL INSERT
Type of DeviceIMPLANT
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
william hanna
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key5001385
MDR Text Key22897408
Report Number0002249697-2015-02654
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 07/17/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/13/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/30/2017
Device Catalogue Number5532-G-611
Device LOT NumberMLHTY0
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 Received09/02/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/21/2012
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: 08/13/2015 Patient Sequence Number: 1
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