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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-511
Device Problem Difficult To Position (1467)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/29/2017
Event Type  Malfunction  
Manufacturer Narrative

Review of the product history records indicates the products were manufactured and accepted into final stock with no 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

Surgeon broke a tibial trial insert during trailing. He also had trouble seating the real tibial insert implant. He felt it was not properly seated and wasted 2 inserts in the process. He felt the medial side was tight and was causing the insert to go in at an angle. Surgeon did not feel there was anything wrong with the implants. The third insert seated properly and locked in to the tibial tray.

 
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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
brian lauro
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key6900794
MDR Text Key87633531
Report Number0002249697-2017-02870
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 11/22/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/28/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number5532-G-511
Device LOT Number70889A
Was Device Available For Evaluation? No
Date Returned to Manufacturer09/18/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/27/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/01/2017
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: 09/28/2017 Patient Sequence Number: 1
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