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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR FEM COMP #5 R-CEM; IMPLANT
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STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR FEM COMP #5 R-CEM; IMPLANT Back to Search Results
Catalog Number 5510F502
Device Problems Delivered as Unsterile Product (1421); Device Packaging Compromised (2916)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/30/2014
Event Type  malfunction  
Event Description
It was reported to field sales manager that when the nurse took packet of triathlon femur during operation and tried to open it, it was noticed that the packet opened not correctly.The plastic of the packet broken and that made implant not sterile.So the customer took another implant which opened correctly.They managed to continue operation, no delay.
 
Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
 
Manufacturer Narrative
An event regarding packaging damage involving a triathlon femoral component was reported.The event was confirmed.The returned outer blister has the flange/lip of one side fully broken off.No other packaging was returned.Device history review for the reported lot determined that the device was manufactured and packed to specification.Complaint history review determined that there were no similar events reported for the lot.The returned outer blister has the flange/lip of one side fully broken off.No other packaging was returned for analysis.Inspection of the entire packaging of the product is required to determine the root cause of this event.If the remaining packaging is returned this investigation will be reopened.No further investigation for this event is possible at this time.
 
Event Description
It was reported to field sales manager that when the nurse took packet of triathlon femur during operation and tried to open it, it was noticed that the packet opened not correctly.The plastic of the packet broken and that made implant not sterile.So the customer took another implant which opened correctly.They managed to continue operation, no delay.
 
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Brand Name
TRIATHLON CR FEM COMP #5 R-CEM
Type of Device
IMPLANT
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-LIMERICK
raheen business park
limerick NA
Manufacturer Contact
niku kasmai
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key3882034
MDR Text Key4541672
Report Number0002249697-2014-02361
Device Sequence Number1
Product Code JWH
Combination Product (y/n)N
Reporter Country CodeFI
PMA/PMN Number
K040267
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 05/30/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/18/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/31/2019
Device Catalogue Number5510F502
Device Lot NumberEF97B
Other Device ID NumberSTERILE LOT EF97B
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/01/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/13/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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