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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 Unstable (1667); Delamination (2904); Material Integrity Problem (2978); Naturally Worn (2988)
Patient Problems Injury (2348); No Code Available (3191)
Event Date 01/24/2017
Event Type  Injury  
Manufacturer Narrative

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

 
Event Description

While revising the patients knee for instability upon exposure, surgeon noted what appears to be delamination on the patella, medial surface of the tibia and backside of the post. The implants were removed and replaced at that time without complication.

 
Manufacturer Narrative

An event regarding instability involving a triathlon patella was reported. The event was not confirmed. -device evaluation and results: visual inspection of returned device was done as a part of mar. Mar confirmed that in-vivo service-related damages to the articulating surfaces of the tibial insert included the cyclic wear mechanisms of delamination and pitting. These are commonly identified damage modes on uhmwpe tibial inserts. Yellow discoloration was also observed on the proximal surfaces. -medical records received and evaluation:not performed as no medical records were provided. -device history review: indicate all devices were manufactured and accepted into final stock with no reported discrepancies. -complaint history review: review of the complaint history confirmed that there were no other similar reported events for the lot. Conclusions: on the basis of mar, the investigation concludes that in-vivo service-related damages to the articulating surfaces of the tibial insert included the cyclic wear mechanisms of delamination and pitting. These are commonly identified damage modes on uhmwpe tibial inserts. Yellow discoloration was also observed on the proximal surfaces. There was no evidence of manufacturing or material defects on the returned ultra-high molecular weight polyethylene (uhmwpe) inserts. However, the exact cause of instability cannot be determined. No further investigation is possible at this time. If additional information becomes available to indicate further evaluation is warranted, this record will be reopened. A capa trend analysis was conducted for the reported failure mode and concluded instability may result from other factors not necessarily related to the device.

 
Event Description

While revising the patients knee for instability upon exposure, surgeon noted what appears to be delamination on the patella, medial surface of the tibia and backside of the post. The implants were removed and replaced at that time without complication.

 
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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
rita intorrella
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key6350744
MDR Text Key68087849
Report Number0002249697-2017-00630
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 04/20/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/22/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/31/2014
Device Catalogue Number5532-G-509
Device LOT NumberMHL627
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/03/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/24/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/06/2009
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: 02/22/2017 Patient Sequence Number: 1
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