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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-600
Device Problems Collapse (1099); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Failure of Implant (1924); Injury (2348)
Event Date 11/30/2015
Event Type  Injury  
Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer. Additional information has been requested but not made available. Should additional information become available it will be reported in a supplemental report upon completion of the investigation. Not returned to the manufacturer.

 
Event Description

It was reported that surgeon revised triathlon baseplate and poly insert due to collapsed patient anterior tibial bone.

 
Manufacturer Narrative

An event regarding tibial subsidence involving a triathlon prim cem fxd bplt was reported. The event was not confirmed. Method & results: -device evaluation and results: not performed as no items were returned. -medical records received and evaluation: not performed as no medical records were provided. -device history review: review of the dhr was satisfactory. -complaint history review: chr confirmed that there are no other similar reported events for the lot. Conclusions: the exact cause of the event could not be determined because insufficient information was provided. Further information such as product details, pre- and post-operative x-rays, operative reports as well as patient history and follow-up notes are needed to complete the investigation for determining a root cause. No further investigation is possible at this time. If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

 
Event Description

It was reported that surgeon revised triathlon baseplate and poly insert due to collapsed patient anterior tibial bone.

 
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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
beverly lima
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key5313534
MDR Text Key33971180
Report Number0002249697-2015-04342
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,Followup
Report Date 11/30/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/21/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/31/2020
Device Catalogue Number5520-B-600
Device LOT NumberTBAYD
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 Received01/29/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/29/2015
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: 12/21/2015 Patient Sequence Number: 1
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