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U.S. Department of Health and Human Services

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

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STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR X3 TIBIAL INSERT PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Model Number 5530-G-409
Device Problems Material Erosion (1214); Insufficient Information (3190)
Patient Problems Fall (1848); Pain (1994); Injury (2348)
Event Date 07/15/2013
Event Type  Injury  
Manufacturer Narrative

Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies. There have been no other similar events for the lot referenced. It was noted that the device is not available for evaluation. Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

 
Event Description

As reported: "event included in the reported submitted as proof of milestone for an investigator initiated study (b)(4). Per the report received 31/march/2020, indication for revision is pain and loosening; tibial liner and tibial baseplate revised. " update 02/june/2020: operative report and exam notes provided by study site report the following: "in late 2012, she had a fall. This did result in some increasing right knee pain. Recent x-rays have shown that she has lateral subluxation and bony erosion as a result of the wear of her patella against the femoral component. Failed right knee arthroplasty with femoral component loosening and polyethylene wear. The patient's patellar component was completely floating in the knee. The tibial component was well aligned. The femoral component was well aligned. " implant record shows that the patient's liner and patellar component were revised. Neither the tibial component or the femoral component were revised.

 
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Brand NameTRIATHLON CR 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
alessandra chavez
2555 davie road
fort lauderdale, FL 33317
9546280700
MDR Report Key10173255
MDR Text Key195716051
Report Number0002249697-2020-01239
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 08/25/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/19/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/31/2013
Device MODEL Number5530-G-409
Device Catalogue Number5530-G-409
Device LOT NumberDMLMHE
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 Received07/28/2020
Was Device Evaluated By Manufacturer? No
Date Device Manufactured05/02/2008
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: 06/19/2020 Patient Sequence Number: 1
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