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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRITANIUM BPLATE TRIATHLON S5 PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

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STRYKER ORTHOPAEDICS-MAHWAH TRITANIUM BPLATE TRIATHLON S5 PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 5536B500
Device Problems Fracture (1260); Unintended Movement (3026)
Patient Problems Injury (2348); Ambulation Difficulties (2544); Inadequate Osseointegration (2646)
Event Date 06/10/2020
Event Type  Injury  
Manufacturer Narrative

An investigation is being performed in an attempt to identify the cause of the event. Should additional information become available it will be reported in a supplemental report. Device not returned.

 
Event Description

It was reported that the patient's left knee was revised due to subsidence of the tibial baseplate. Intra-operatively, it was noted that the baseplate is fractured. The baseplate and liner were revised. No allegations against the revised liner were reported.

 
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Brand NameTRITANIUM BPLATE TRIATHLON S5
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 NJ NA
EI NA
Manufacturer Contact
diana rogers
210 centennial avenue
centennial park, elstree
borehamwood WD6 3-SJ
UK   WD6 3SJ
2082386500
MDR Report Key10329681
MDR Text Key200606668
Report Number0002249697-2020-01547
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,Followup
Report Date 10/20/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/27/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number5536B500
Device LOT NumberCTD11403
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 Received09/23/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/11/2016
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: 07/27/2020 Patient Sequence Number: 1
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