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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM BEAD PA SZE4 BP PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

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STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM BEAD PA SZE4 BP PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 5526B400
Device Problems Malposition of Device (2616); Positioning Problem (3009)
Patient Problem Injury (2348)
Event Date 09/09/2017
Event Type  Injury  
Manufacturer Narrative

An event regarding wear involving an insert was reported. Baseplate the event was confirmed. Conclusions: a review of the provided medical records and x-rays by a clinical consultant indicated: baseplate malposition in high posterior tibial slope has contributed to flexion instability with overload in the arthroplasty and consequently abnormal bearing wear requiring revision with tibial bearing exchange. No further investigation is possible at this time. If additional information becomes available to indicate further evaluation is warranted, this record will be reopened. Not returned.

 
Event Description

Insert change due to poly wear. Update: per medical review "baseplate malposition in high posterior tibial slope has contributed to flexion instability with overload in the arthroplasty and consequently abnormal bearing wear requiring revision with tibial bearing exchange. ".

 
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Brand NameTRIATHLON PRIM BEAD PA SZE4 BP
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
timothy rice
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key7182881
MDR Text Key96990516
Report Number0002249697-2018-00135
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeSE
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 02/13/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/11/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/30/2018
Device Catalogue Number5526B400
Device LOT NumberEEFLP
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/18/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/18/2013
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: 01/11/2018 Patient Sequence Number: 1
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