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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM BEAD PA SZE6 BP KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS

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STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM BEAD PA SZE6 BP KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS Back to Search Results
Catalog Number 5526B600
Device Problems Malposition of Device (2616); Positioning Problem (3009); Insufficient Information (3190)
Patient Problems Inflammation (1932); Injury (2348); Reaction (2414)
Event Date 04/03/2018
Event Type  Injury  
Manufacturer Narrative

A review of the device history records indicates that the reported devices were manufactured and accepted into final stock with no reported discrepancies. The complaint history review indicated that there were no similar events for the reported lot. An evaluation of the device cannot be performed as the device was not returned to the manufacturer. Should additional information become available, the evaluation summary will be submitted in a supplemental report. Not returned.

 
Event Description

A knee revision was reported for instability.

 
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Brand NameTRIATHLON PRIM BEAD PA SZE6 BP
Type of DeviceKNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS
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
keyla colon
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key7529589
MDR Text Key108750575
Report Number0002249697-2018-01499
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeSE
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 08/22/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/21/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/28/2018
Device Catalogue Number5526B600
Device LOT NumberEB6MX
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/16/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/25/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/13/2013
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: 05/21/2018 Patient Sequence Number: 1
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