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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRI TS BASEPLATE SIZE 4 PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

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STRYKER ORTHOPAEDICS-MAHWAH TRI TS BASEPLATE SIZE 4 PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 5521-B-400
Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problem Injury (2348)
Event Date 11/20/2018
Event Type  Injury  
Manufacturer Narrative

Reported event: an event regarding tibial loosening involving a triathlon ts baseplate component was reported. The event was not confirmed. Method & results: device evaluation and results: not performed as product was not returned. Medical records received and evaluation: no medical records were received for review with a clinical consultant. Device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies. Complaint history review: there have been no other similar events for the reported lot. Conclusion: the exact cause of the event could not be determined because insufficient information was provided. Additional information, including operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event. If further information becomes available or the product is returned, this investigation will be re-opened.

 
Event Description

It was reported through the submission of a primary and a revision implant sheet, that the patient's right knee was revised. Comparing the sheets, a 4x11 cs insert and size 4 universal tibial baseplate were revised to a 4x19 cs insert, another size 4 universal tibial baseplate with a 12x100 cemented stem and 4x5 tibial augment. It was later reported that the patient's grandson jumped on patient's knee which caused loosening of the tibial component. The tibial component and liner were revised as originally reported.

 
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Brand NameTRI TS BASEPLATE SIZE 4
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
anna smith
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key8174007
MDR Text Key130654500
Report Number0002249697-2018-04060
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 12/18/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/18/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number5521-B-400
Device LOT NumberVS3AA
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 Received11/20/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/04/2016
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: 12/18/2018 Patient Sequence Number: 1
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