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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #5 9MM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

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STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #5 9MM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 5531G509
Device Problems Difficult To Position (1467); Device Operates Differently Than Expected (2913); Positioning Problem (3009)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/09/2017
Event Type  Malfunction  
Manufacturer Narrative

Review of the device history records indicates the devices were manufactured and accepted into final stock with no reported discrepancies. There have been no other events for the lot referenced. A supplemental report will be submitted upon completion of the investigation.

 
Event Description

Sales rep received a phone call from (b)(6) hospital (b)(6) 2017 - surgeon was unable to implant item ref 5531g509 in the operation (b)(6) 2017. After 4th trial to place the implant surgeon changed the implant to a new 5531g509 and was able to implant the this item without any issue.

 
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Brand NameX3 TRIATHLON CS INSERT #5 9MM
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
timothy rice
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key7096489
MDR Text Key94960599
Report Number0002249697-2017-03510
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeFI
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 02/09/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/07/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number5531G509
Device LOT NumberLFP438
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/21/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/11/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/15/2017
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: 12/07/2017 Patient Sequence Number: 1
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