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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 KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS

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STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM BEAD PA SZE4 BP KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS Back to Search Results
Catalog Number 5526B400
Device Problems Malposition of Device (2616); Positioning Problem (3009)
Patient Problem Injury (2348)
Event Date 05/22/2018
Event Type  Injury  
Manufacturer Narrative

An event regarding malposition leading to instability involving a triathlon insert was reported. The event was confirmed through the device return and analysis. Method and results: device evaluation and results: a material analysis has been performed. The report concluded: damage was observed on the femoral component, insert and baseplate consistent with contact against each other. Debris was observed on the insert, likely from the femoral component. Eds showed the femoral component, baseplate and debris were consistent with astm f75 alloy. Burnishing, scratching and third-body indentations were observed on the insert. These are common damage modes of uhmwpe. Explantation damage and markings consistent with contact against the baseplate were also observed on the insert. Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined. -medical records received and evaluation: baseplate malposition in excessive posterior tibial slope has caused flexion instability of the knee with the femoral component riding over the posterior border of the baseplate with poly bearing causing poly wear and metallosis due to metal-metal contact between femur and tibia requiring revision after 7-years. Device history review: indicated all devices were manufactured and accepted into final stock with no reported discrepancies. Complaint history review: there have been no other similar events for the lot referenced. Conclusions: material analysis concluded: damage was observed on the femoral component, insert and baseplate consistent with contact against each other. Debris was observed on the insert, likely from the femoral component. Eds showed the femoral component, baseplate and debris were consistent with astm f75 alloy. Burnishing, scratching and third-body indentations were observed on the insert. These are common damage modes of uhmwpe. Explantation damage and markings consistent with contact against the baseplate were also observed on the insert. Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined. The medical review concluded that baseplate malposition in excessive posterior tibial slope has caused flexion instability of the knee with the femoral component riding over the posterior border of the baseplate with poly bearing causing poly wear and metallosis due to metal-metal contact between femur and tibia requiring revision after 7-years. No further investigation is required at this time. If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

 
Event Description

Knee revision due to instability. Update based on med review: baseplate malposition in excessive posterior tibial slope has caused flexion instability of the knee with the femoral component riding over the posterior border of the baseplate with poly bearing causing poly wear and metallosis due to metal-metal contact between femur and tibia requiring revision after 7-years.

 
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Brand NameTRIATHLON PRIM BEAD PA SZE4 BP
Type of DeviceKNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS
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
keyla colon
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key7874091
MDR Text Key120192003
Report Number0002249697-2018-02858
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
Report Date 09/13/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/13/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/31/2016
Device Catalogue Number5526B400
Device LOT NumberS36DC1
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/12/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/21/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/11/2011
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: 09/13/2018 Patient Sequence Number: 1
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