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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-709
Device Problem Insufficient Information (3190)
Patient Problems Pain (1994); Synovitis (2094); Injury (2348)
Event Date 04/13/2017
Event Type  Injury  
Manufacturer Narrative

The following devices were also listed in this report: triathlon asymmetric x3 patella; cat# 5551-g-381; lot# vxkw. Tri ts baseplate size 7; cat# 5521-b-700; lot# jbkn. Triathlon ps fem comp #7r-cem; cat# 5515f702; lot# at77y. It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience. 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. 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.

 
Event Description

It was reported through the communication of an attorney that allegedly the patient was revised due to " right knee pain, hypertrophic synovium, status-post total knee arthroplasty. ".

 
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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-LIMERICK
raheen business park
limerick NA
Manufacturer Contact
collin neitzel
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key8687087
MDR Text Key147601208
Report Number0002249697-2019-02210
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 06/11/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/11/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date12/01/2019
Device Catalogue Number5532-G-709
Device LOT NumberLEB241
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
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 Manufactured11/19/2014
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: 06/11/2019 Patient Sequence Number: 1
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