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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN STRYKER TRIATHLON PS KNEE PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

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STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN STRYKER TRIATHLON PS KNEE PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number UNK_JR
Device Problem Insufficient Information (3190)
Patient Problems Unspecified Infection (1930); Injury (2348); Inadequate Osseointegration (2646)
Event Date 03/01/2015
Event Type  Injury  
Manufacturer Narrative

It was noted that the device is not available for evaluation. If additional information is received, it will be provided in a supplemental report upon completion of the investigation.

 
Event Description

This pi is for patient 2 of 2. In an excerpt from the 2018 dkg annual meeting, "cruciate retaining versus posterior stabilized total knee arthroplasty for the treatment of valgus osteoarthritis?" the following is noted: ". 2/44 patients were revised in the ps group due to infection or aseptic loosening. ".

 
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Brand NameUNKNOWN STRYKER TRIATHLON PS KNEE
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
brad curtis
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key10513140
MDR Text Key206350278
Report Number0002249697-2020-01832
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeDE
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type LITERATURE,OTHER
Reporter Occupation
Type of Report Initial
Report Date 09/10/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/10/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNK_JR
Device LOT NumberUNKNOWN
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 Received08/18/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 09/10/2020 Patient Sequence Number: 1
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