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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM CEM FXD BPLT #5 PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

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STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM CEM FXD BPLT #5 PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 5520B500
Device Problem Migration (4003)
Patient Problem Injury (2348)
Event Date 07/11/2019
Event Type  Injury  
Manufacturer Narrative

The following devices were also listed in this report: triathlon ps fem component, cemented; cat#: 5515-f-401; lot#: se74r. 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. Device not returned.

 
Event Description

Revision surgery: chronic gonalgia in outcome of arthrosurface cfm patient underwent the first left knee arthroplasty implant due to a gonarthrosis. Updated by qs on 13-nov-2019: per provided medical review comment: x-ray dated (b)(6) 2019 is an ap of the left knee - patella not visualized, a primary tka is in place with no visible cement with the tibial component subsided medially resulting in a varus deformity of the knee.

 
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Brand NameTRIATHLON PRIM CEM FXD BPLT #5
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 Key9452724
MDR Text Key184866468
Report Number0002249697-2019-04002
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeIT
PMA/PMN NumberK141056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,OTHER
Reporter Occupation RISK MANAGER
Type of Report Initial,Followup
Report Date 12/19/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/11/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date11/30/2012
Device Catalogue Number5520B500
Device LOT NumberSFCXC
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/12/2019
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/22/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/13/2007
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: 12/11/2019 Patient Sequence Number: 1
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