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U.S. Department of Health and Human Services

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

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STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS X3 TIBIAL INSERT PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 5532-G-611
Device Problem Insufficient Information (3190)
Patient Problems Pain (1994); Injury (2348); Disability (2371)
Event Date 06/08/2018
Event Type  Injury  
Manufacturer Narrative

An event regarding pain involving a triathlon insert was reported. The event was not confirmed. Method & results: product evaluation and results: not performed as the device was not returned. Medical records received and evaluation: not performed as no medical records were returned for review. Product history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies. Complaint history review: there have been no other similar events for the reported lot. Conclusions: the exact cause of the event could not be determined because insufficient information was provided. Further information such as evaluation of the device, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause. No further investigation for this event is possible at this time as no devices and insufficient information was received by stryker orthopaedics. If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened. The following devices were also listed in this report: triathlon p/a ps beaded #6r; cat# 5516f602; lot# byh9y; tritanium bplate triathlon s6; cat# 5536b600 ; lot# ctd16644; tritanium patella-asymmetric; cat# 5552-l-350 ; lot# d0ad. It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.

 
Event Description

"procedure: patient underwent right total knee replacement (b)(6) 2017. Patient returned for pain and disability. Patient underwent revision on (b)(6) 2018 for suspicion of femoral component loosening (based on a bone scan), at surgery all components were found to be well fixed. Only poly was exchanged. ".

 
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Brand NameTRIATHLON PS 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
brad curtis
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key7968835
MDR Text Key123813278
Report Number0002249697-2018-03361
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 OTHER,STUDY
Reporter Occupation
Type of Report Initial
Report Date 10/16/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/16/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number5532-G-611
Device LOT NumberMN0KA3
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 Received09/18/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/27/2017
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: 10/16/2018 Patient Sequence Number: 1
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