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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-609
Device Problems Device Abrasion From Instrument Or Another Object (1387); Defective Device (2588); Material Deformation (2976)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 09/26/2016
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

It has been reported that the reference 5532-g-609 tibial bearing insert 6/9mm seems to have a defect.

 
Manufacturer Narrative

An event regarding fitting issue involving a triathlon insert was reported. The event was not confirmed. Method & results: device evaluation and results: the device was returned in damage condition. The anterior bearing surface of the insert shows minor pitting and light scratches consistent with short clinical use. The locking wire found disassemble from the insert. Examination of the returned device with material analysis engineer indicated that damage on the anterior surface of the insert at the location of the locking wire. Damage likely allowed locking wire to disassemble from the insert. 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 as the device was returned in damage condition. Material analysis engineer indicated that the damage observed at the location of the locking wire which likely allowed locking wire to disassemble from the insert. Due to this, functional and dimensional test could not be performed. Thus, the exact cause of fitting issue could not be determined. If additional information becomes available, this investigation will be reopened.

 
Event Description

It has been reported that the reference (b)(4) tibial bearing insert 6/9mm seems to have a defect. Our customer has reported that the defect is: the metallic part was defective and the polyethylene did not fit into the tibial base.

 
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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-LIMERICK
raheen business park
limerick NA
Manufacturer Contact
cindy chuhinko
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key6213609
MDR Text Key63804786
Report Number0002249697-2016-04052
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
PMA/PMN NumberK141056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,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 Received12/29/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number5532-G-609
Device LOT NumberYT5MVK
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/30/2017
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/23/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/03/2015
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: 12/29/2016 Patient Sequence Number: 1
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