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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS FEM COMPONENT, CEMENTED PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

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STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS FEM COMPONENT, CEMENTED PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 5515-F-501
Device Problems Entrapment of Device (1212); 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 10/03/2016
Event Type  Malfunction  
Manufacturer Narrative

Additional information has been requested. Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

 
Event Description

Rep reported the inner tray was stuck in the outer tray and would not come out.

 
Manufacturer Narrative

An event regarding difficulty removing the inner blister from the packaging. The event was not confirmed. Method & results: device evaluation and results: based on the visual inspection of the returned packaging it appears that this component packaging was subjected to excessive/inappropriate handling during transportation/storage whereby the carton had been compressed and potentially causing the reported difficulty removing the inner tray from the outer tray, however it must be noted that the inner blister was removed without difficulty during the visual inspection. Medical records received and evaluation: not performed as the event is related to a packaging issue and no adverse consequences to the patient were reported. Device history review: dhr review for the reported lot determined that the device was manufactured and packed to specification. Complaint history review: there have been no other events for the lot referenced. Conclusions: the investigation noted that the component packaging was subjected to excessive/inappropriate handling during transportation/storage whereby the carton had been compressed potentially causing the reported difficulty removing the inner tray from the outer tray. However the inner blister was removed without difficulty during the visual inspection and as such a definite route cause cannot be determined. No further investigation for this event is required at this time.

 
Event Description

Rep reported the inner tray was stuck in the outer tray and would not come out.

 
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Brand NameTRIATHLON PS FEM COMPONENT, 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-LIMERICK
raheen business park
limerick NA
Manufacturer Contact
joann lavatelli
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key6064433
MDR Text Key59021976
Report Number0002249697-2016-03398
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 12/29/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/28/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number5515-F-501
Device LOT NumberUERDD
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/11/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/02/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/18/2016
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: 10/28/2016 Patient Sequence Number: 1
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