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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRI TS BASEPLATE SIZE 6 PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

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STRYKER ORTHOPAEDICS-MAHWAH TRI TS BASEPLATE SIZE 6 PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 5521-B-600
Device Problems Failure To Adhere Or Bond (1031); Insufficient Information (3190)
Patient Problems Injury (2348); No Known Impact Or Consequence To Patient (2692)
Event Date 09/13/2016
Event Type  Injury  
Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer due to hospital policy. Additional information has been requested. 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

Tibia implant loose.

 
Manufacturer Narrative

An event regarding tibial component loosening involving a triathlon baseplate was reported. The event was not confirmed. Method & results: -device evaluation and results: not performed as the subject device was not returned for evaluation. -medical records received and evaluation: not performed as no medical records were provided. -device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies. -complaint history review: chr review indicated that there were no other similar events reported for the subject manufacturing lot. Conclusions: an event regarding tibia component loosening involving a triathlon baseplate was reported. Neither the event could be confirmed nor the root cause of the event could be determined because insufficient information was provided. Further information such as device evaluation, x-rays, operative notes and patient details are required to further investigate this event to determine a root cause. No further investigation for this event is possible at this time. If additional information becomes available, this investigation will be reopened.

 
Event Description

Tibia implant loose.

 
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Brand NameTRI TS BASEPLATE SIZE 6
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
cindy chuhinko
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key6013491
MDR Text Key56922240
Report Number0002249697-2016-03184
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 COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/19/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/10/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/31/2016
Device Catalogue Number5521-B-600
Device LOT NumberBRZP
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/20/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/11/2011
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: 10/10/2016 Patient Sequence Number: 1
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