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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRI RM/LL TIB AUG SZ5 5MM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

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STRYKER ORTHOPAEDICS-MAHWAH TRI RM/LL TIB AUG SZ5 5MM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 5545-A-502
Device Problems Failure To Adhere Or Bond (1031); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 05/24/2017
Event Type  Malfunction  
Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

 
Event Description

During surgery the surgeon noticed that the tibial augment could not be fixed to the implant. There was a 15 min surgical delay when looking for a new device. Patient not affected in any other way.

 
Manufacturer Narrative

An event regarding assembly issue involving an triathlon augment was reported. The event was not confirmed. Device evaluation and results: a functional inspection found the device to be fully functional. The returned tibial augment was mated with a triathlon baseplate, catalog 5521-b-500 lot ao34ba, from finished goods and the locking screw on the augment was able to be locked in the baseplate. Medical records received and evaluation: no medical records or x-rays were made available for evaluation. Device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies complaint history review: there has been no other event for the lot referenced. Conclusions: the event could not be confirmed as the reported event could not be duplicated. The functional inspection found the device to be fully functional as the locking was screw was able to lock into the triathlon baseplate. No further investigation for this event is possible at this time.

 
Event Description

During surgery the surgeon noticed that the tibial augment could not be fixed to the implant. There was a 15 min surgical delay when looking for a new device. Patient not affected in any other way.

 
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Brand NameTRI RM/LL TIB AUG SZ5 5MM
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 Key6659263
MDR Text Key78247767
Report Number0002249697-2017-01966
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeSE
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 09/12/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/21/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number5545-A-502
Device LOT NumberERDKD0A
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/29/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/16/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/26/2016
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: 06/21/2017 Patient Sequence Number: 1
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