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U.S. Department of Health and Human Services

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

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STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS X3 TIBIAL INSERT PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 5532-G-509
Device Problems Mechanical Problem (1384); Device Operates Differently Than Expected (2913); Mechanical Jam (2983); Positioning Problem (3009); Locking Mechanism (3083)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/21/2016
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

Per sales rep, patient had primary knee implant. The insert did not lock in the base plate. It was removed and a new one was put in place.

 
Manufacturer Narrative

An event regarding a locking issue involving a triathlon insert was reported. The event was confirmed. Method & results: -device evaluation and results: visual inspection of the returned device indicates scratches and some explantation damages. Review of device by material analysis engineer indicated: "damage consistent with explantation and slight damage observed on the posterior surface of the insert possible malalignment. " -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: a visual inspection of returned device shows scratches and some explantation damages on the posterior surface of the insert. Material analysis engineer concluded that the insert could not be successfully seated into the baseplate, likely it was misalignment during implantation. No further investigation for this event is required at this time, if additional information becomes available, this investigation will be reopened.

 
Event Description

Per sales rep, patient had primary knee implant. The insert did not lock in the base plate. It was removed and a new one was put in place.

 
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Brand NameTRIATHLON PS 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
cindy chuhinko
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key6111420
MDR Text Key60636127
Report Number0002249697-2016-03654
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 02/15/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/17/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number5532-G-509
Device LOT Number9377A5
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/01/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/20/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/22/2016
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: 11/17/2016 Patient Sequence Number: 1
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