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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON #6 PS INSERT 11MM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

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STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON #6 PS INSERT 11MM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 5532P611
Device Problems Failure to Align (2522); Mechanical Jam (2983); Positioning Problem (3009)
Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)
Event Date 12/11/2016
Event Type  Malfunction  
Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

 
Event Description

Per sales rep (b)(6) 2016: the liners were not broken but were both malalligned upon impaction. They were not able to lock in. The surgeon tried three times.

 
Manufacturer Narrative

An event regarding a seating/locking issue involving a triathlon insert was reported. The event was confirmed by visual inspection. Method & results: -device evaluation and results: the posterior tabs and edges of the retaining slot wall on inferior surface of the insert all show damage consistent with the insert having been incorrectly presented to the baseplate during assembly. It would appear that the plastic tabs were pressed against the front end of the metal retaining tabs of the baseplate rather than underneath the metal tabs. The observed damage on the locking wire is indicative of attempted assembly of the insert onto the baseplate. -medical records received and evaluation: not performed as no medical records were provided. -device history review: dhr review for the reported lot was satisfactory. -complaint history review: chr review for the reported lot confirmed that there are no other similar events reported. Conclusions: based on the visual inspection of the returned component, the observed damage on the posterior aspect and inferior edge of the retaining slot wall of the insert is indicative of an obstruction during attempted seating of the insert onto the baseplate. The observed damage on the locking wire is indicative of attempted assembly of the insert onto the baseplate. No further investigation for this event is required at this time.

 
Event Description

Per sales rep 12/13/2016: the liners were not broken but were both malalligned upon impaction. They were not able to lock in. The surgeon tried three times.

 
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Brand NameTRIATHLON #6 PS INSERT 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
cindy chuhinko
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key6234498
MDR Text Key64599360
Report Number0002249697-2017-00136
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeCA
PMA/PMN NumberK141056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/24/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/09/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number5532P611
Device LOT NumberLFE967A
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/17/2017
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/24/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/01/2016
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: 01/09/2017 Patient Sequence Number: 1
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