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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #6 11MM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

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STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #6 11MM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Model Number 5531-G-611
Device Problem Insufficient Information (3190)
Patient Problems Unspecified Infection (1930); Injury (2348)
Event Date 02/04/2020
Event Type  Injury  
Manufacturer Narrative

Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies. There have been no other events for the lot referenced. If additional information is received, it will be provided in a supplemental report upon completion of the investigation. The following devices were also listed in this report: triathlon p/a cr beaded #6r; 5517f602; elfdt, tritanium bplate triathlon s6; 5536b600;ctd7604. It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience. Device not returned.

 
Event Description

Procedure: the patient underwent left knee primary osteoarthritis (b)(6) 2015. Patient underwent right total knee revision surgery for the infection (b)(6) 2020. Only poly exchanged.

 
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Brand NameX3 TRIATHLON CS INSERT #6 11MM
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
NA
Manufacturer Contact
alessandra chavez
2555 davie road
fort lauderdale, FL 33317
9546280700
MDR Report Key10472356
MDR Text Key204981113
Report Number0002249697-2020-01762
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
Reporter Occupation
Type of Report Initial
Report Date 08/31/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/31/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/30/2020
Device MODEL Number5531-G-611
Device Catalogue Number5531G611
Device LOT NumberLEL453
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/05/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/30/2015
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: 08/31/2020 Patient Sequence Number: 1
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