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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-502
Device Problems Manufacturing, Packaging or Shipping Problem (2975); Adverse Event Without Identified Device or Use Problem (2993); Packaging Problem (3007)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/25/2016
Event Type  malfunction  
Manufacturer Narrative
When completed, the investigation results will be submitted in a supplemental report.
 
Event Description
During a right total knee arthroplasty, upon opening the implants (femur), the tech was unable to retrieve the implant out of the primary packaging.It looked like the secondary packaging was pressed into the primary packaging.He elected to open another implant.There was a surgical delay of approximately 2 minutes.No adverse consequence to the patient.
 
Manufacturer Narrative
The device was returned in used condition and in its original packaging.The packaging shrink wrap was intact except for the opened portion of the outer box.The outer blister tyvek portion was opened.There were no signs of damage to the plastic blister or tyvek lid.The inner portion of the packaging was damaged.It appeared the tyvek lid could not be opened.There were holes in various areas of the tyvek lid.There was a larger hole located in the lower right corner.The inner package tyvek lid was not opened.During the functional test of the inner blister tyvek lid, it opened as intended.Not performed as medical records were not returned.Review of the device history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for this lot.The returned device packaging, the inner blister¿s tyvek lid was able to be opened as intended.The complaint could not be replicated and therefore could not be confirmed.The exact cause of the event could not be determined because during a functional test on.
 
Event Description
During a right total knee arthroplasty, upon opening the implants (femur), the tech was unable to retrieve the implant out of the primary packaging.It looked like the secondary packaging was pressed into the primary packaging.He elected to open another implant.There was a surgical delay of approximately 2 minutes.No adverse consequence to the patient.
 
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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-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer Contact
keyla colon
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key5894838
MDR Text Key52723736
Report Number0002249697-2016-02685
Device Sequence Number1
Product Code MBH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K141056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 07/25/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/31/2017
Device Catalogue Number5515-F-502
Device Lot NumberFKLR
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/02/2016
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/25/2016
Initial Date FDA Received08/22/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received10/26/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/23/2012
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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