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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM TIB BASEPLATE - CEMENTED PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

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STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM TIB BASEPLATE - CEMENTED PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 5520-B-400
Device Problems Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)
Patient Problems Injury (2348); Non-union Bone Fracture (2369)
Event Date 12/20/2018
Event Type  Injury  
Manufacturer Narrative

An event regarding loosening involving a triathlon baseplate was reported. The event was not confirmed. Method & results: product evaluation and results: not performed as the device was not returned. Medical records received and evaluation: not performed as no medical records were returned for review. Product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies. Complaint history review: there were no other events for the lot provided. Conclusions: the exact cause of the event could not be determined because insufficient information was provided. Further information such as device return, pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause. No further investigation for this event is possible at this time as no devices and insufficient information was received by stryker orthopaedics. If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.

 
Event Description

It was reported through the submission of a revision implant sheet that patient's left knee was revised. In comparing the primary and revision implant sheets, a size 4 cr femoral component, size 4 baseplate, and 4x11cs insert were revised to a 9 device ts knee construct with stems and augments. Update 11/january/2018. Rep called to provide additional information. Surgeon reported that at the time of primary implant, patient had inadequate internal fixation to address a tibial plateau fracture. The plate failed to address the fracture and the resulting nonunion contributed to the collapse of the tibial plateau and failure of the implants.

 
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Brand NameTRIATHLON PRIM TIB BASEPLATE - CEMENTED
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
joann lavatelli
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key8257837
MDR Text Key133386779
Report Number0002249697-2019-00218
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
Report Date 01/17/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/17/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number5520-B-400
Device LOT NumberVTIYB
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 Received12/20/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/12/2016
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: 01/17/2019 Patient Sequence Number: 1
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