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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-302
Device Problems Delivered as Unsterile Product (1421); Device Packaging Compromised (2916); Manufacturing, Packaging or Shipping Problem (2975); Packaging Problem (3007)
Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Event Date 06/10/2015
Event Type  malfunction  
Event Description
Our customer reported that the sterility of the device was not guaranteed, because the package upon opening was not sealed in its interior.At our request if the device is now still in the original packaging, customer said that the package has been opened and only after they realized that the package was not sterile.No surgical delay because another device was available.
 
Manufacturer Narrative
When completed, the investigation results will be submitted in a supplemental report.
 
Manufacturer Narrative
An event regarding pack damage involving a triathlon femoral component was reported.The event was confirmed.Method & results: -device evaluation and results: based on the review by the packaging engineering department, there is nowhere in the process that this type of damage could occur.In order to line up the damage observed on the inside of the carton and the damage on the tyvek lid, the blister would have to be placed in the carton incorrectly.-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: based on the review by the packaging engineering department, there is nowhere in the process that this type of damage could have occurred.In order to line up the damage observed on the inside of the carton and the damage on the tyvek lid, the blister pack would have to be placed in the carton incorrectly; it is unlikely that this occurred during the packaging process.No further investigation for this event is possible at this time.If additional information becomes available, this investigation will be reopened.
 
Event Description
Our customer reported that the sterility of the device was not guaranteed, because the package upon opening was not sealed in its interior.At our request if the device is now still in the original packaging, customer said that the package has been opened and only after they realized that the package was not sterile.No surgical delay because another device was available.
 
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Brand Name
TRIATHLON PS FEM COMPONENT, CEMENTED
Type of Device
PROSTHESIS, 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
william hanna
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key4899392
MDR Text Key6065531
Report Number0002249697-2015-02240
Device Sequence Number1
Product Code MBH
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K141056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Company Representative,company representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 06/11/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/08/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/30/2020
Device Catalogue Number5515-F-302
Device Lot NumberEMR7C
Other Device ID NumberSTERILE LOT# T4112
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received09/25/2015
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/16/2015
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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