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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM TIB BASEPLATE - CEMENTED PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C

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STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM TIB BASEPLATE - CEMENTED PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C Back to Search Results
Catalog Number 5520-B-300
Device Problem Insufficient Information (3190)
Patient Problems Nerve Damage (1979); Pain (1994); Swelling (2091); Thyroid Problems (2102); Ambulation Difficulties (2544)
Event Date 10/26/2017
Event Type  Injury  
Manufacturer Narrative

Review of the product history records indicates products were manufactured and accepted into final stock with no 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. Device not available.

 
Event Description

It's alleged by the patient through the filing of a claim that she underwent a total knee arthroplasty on an unknown date. It is further alleged that after implantation the patient began experiencing "pain, swelling, difficulty walking, nerve damage, thyroid problems, shin conditions and high levels of cobalt and chromium". ¿on (b)(6) 2007 the patient was admitted for "left hip pain. Few months. Complains of mild discomfort right knee. With 110° of flexion. Plan: left total hip arthroplasty and manipulation under anesthesia right knee. Uses tobacco products. " on (b)(6) 2007 there is an operative report for a closed manipulation under anesthesia of the right knee and a left total hip arthroplasty for a diagnosis of "left hip arthrosis and post-operative arthrofibrosis right tka". The operative report notes spinal anesthesia and a posterolateral approach for the hip. Prior to the hip arthroplasty a manipulation under anesthesia of the right knee was performed for a pre-operative range of motion noted to be 0° to 85° and post manipulation it was noted to be "well over 120° of flexion". ¿.

 
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Brand NameTRIATHLON PRIM TIB BASEPLATE - CEMENTED
Type of DevicePROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C
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
merin grace
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key7768753
MDR Text Key116624570
Report Number0002249697-2018-02454
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 CONSUMER,OTHER
Reporter Occupation
Type of Report Initial
Report Date 08/09/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/09/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/31/2011
Device Catalogue Number5520-B-300
Device LOT NumberUHZY
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/12/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/30/2005
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: 08/09/2018 Patient Sequence Number: 1
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