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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, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

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STRYKER ORTHOPAEDICS-MAHWAH NO 4. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 13MM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 5537-G-413
Device Problems Lock (870); Plate (907); Mechanical Problem (1384); Difficult To Position (1467); Inadequacy of Device Shape and/or Size (1583); Device Slipped (1584); Positioning Problem (3009)
Patient Problems Injury (2348); No Information (3190)
Event Date 10/05/2015
Event Type  Malfunction  
Manufacturer Narrative

When completed, the investigation results will be submitted in a supplemental report.

 
Event Description

Original poly impaction was attempted, dr. (b)(6) attempted to impact numerous times and the poly refuse to lock into baseplate. Only 1 poly of that size was available so the doctor chose to go down 1 size and the poly was impacted and locked into baseplate on first try.

 
Manufacturer Narrative

An event regarding a no 4. Triathlon ts plus tibial insert x3 poly 13mm not locking into a baseplate during primary surgery was reported. The event was confirmed. Method & results: - device evaluation and results: the tibial insert was returned in used condition. There were minor nicks and burrs throughout, small indentations near the stem and on the bottom, and damage to one corner. The observed damage indicates the tibial insert was not positioned properly in te baseoplate prior to impaction (the tibial insert was not seated under the lip of the baseplate). Subsequent impactions resulted in further deformation of the tibial insert. - medical records received and evaluation: no medical records were received for review with a clinical consultant. - device history review: device history review confirmed all devices accepted into finished goods conformed to specification. - complaint history review: no other events were reported for the lot indicated. Conclusions: the tibial insert displayed small indentations near the stem and on the bottom, minor nicks and burrs throughout, and damage to one corner. The observed damage indicates the tibial insert was not positioned properly in te baseoplate prior to impaction (the tibial insert was not seated under the lip of the baseplate). Subsequent impactions resulted in further deformation of the tibial insert. Inspection by stryker material analysis confirmed that these indentations, nicks and burrs were consistent with indications of an unsuccessful insertion (attempted locking) of the tibial insert into the baseplate.

 
Event Description

Original poly impaction was attempted, dr. (b)(6) attempted to impact numerous times and the poly refuse to lock into baseplate. Only 1 poly of that size was available so the doctor chose to go down 1 size and the poly was impacted and locked into baseplate on 1st try.

 
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Brand NameNO 4. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 13MM
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
keyla navedo
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key5195937
MDR Text Key30476694
Report Number0002249697-2015-03552
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 10/05/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/02/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/30/2019
Device Catalogue Number5537-G-413
Device LOT NumberMNH643
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/20/2015
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/19/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/17/2014
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: 11/02/2015 Patient Sequence Number: 1
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