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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRI CEMENTED STEM 12MMX100MM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C

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STRYKER ORTHOPAEDICS-MAHWAH TRI CEMENTED STEM 12MMX100MM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C Back to Search Results
Catalog Number 5560-S-212
Device Problems Corroded (1131); Loss of Osseointegration (2408)
Patient Problems Pain (1994); Injury (2348); Inadequate Osseointegration (2646)
Event Date 05/14/2012
Event Type  Injury  
Manufacturer Narrative

The information in this report was provided by stryker orthopaedics legal affairs department. No additional information is available at this time due to the ongoing litigation. Should additional information become available, the evaluation summary will be submitted in a supplemental report. Device not returned for evaluation.

 
Event Description

Letter received from patient's lawyers advising the stryker ts triathlon knee replacement is "defective and materially contributed to ongoing left lower limb problems including the development of a pseudo-tumour". Patient is reports left knee problems following surgery on the (b)(6) 2012. Please see communication log for details regarding additional information.

 
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Brand NameTRI CEMENTED STEM 12MMX100MM
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
collin neitzel
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key8229285
MDR Text Key132564876
Report Number0002249697-2019-00114
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeAU
PMA/PMN NumberK141056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/11/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/08/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date12/31/2015
Device Catalogue Number5560-S-212
Device LOT NumberN5S11H
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/14/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/10/2010
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: 01/08/2019 Patient Sequence Number: 1
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