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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-613
Device Problems Difficult to Insert (1316); Defective Device (2588)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/06/2018
Event Type  Malfunction  
Manufacturer Narrative

Review of the product 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. A supplemental report will be submitted upon completion of the investigation.

 
Event Description

During a primary left tka while inserting the polyethylene insert it was reported to me that ¿the locking wire was sticking out after fully seating the insert¿. A new insert was opened and inserted successfully. Update 10/december/2018: surgical delay. As reported in adverse consequences details: "the procedure was prolonged for an extra 2 minutes while removing the affected insert and implanting a new one. ".

 
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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
joanne mahony
ida industrial estate
carrigtwohill NA
214532800
MDR Report Key8214681
MDR Text Key132544169
Report Number0002249697-2019-00022
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 HEALTH PROFESSIONAL,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/12/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/03/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number5532-G-613
Device LOT Number82208317C
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/14/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/12/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/27/2018
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: 01/03/2019 Patient Sequence Number: 1
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