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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-402
Device Problems Loose or Intermittent Connection (1371); Mechanical Jam (2983); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Event Date 11/01/2016
Event Type  Malfunction  
Manufacturer Narrative

It was noted that the device is not available for evaluation. Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.

 
Event Description

The inner blister was stuck inside the outer blister and would not come loose.

 
Manufacturer Narrative

An event regarding packaging issue of the removal of the inner blister pack involving a triathlon ps fem component, cemented was reported. The event was not confirmed. Method & results: -device evaluation and results: a functional test was conducted to test the removal of the inner blister from the outer blister. The inner blister was well seated within the outer blister. When turned upside down the inner blister was seated securely. Placing a thumb in one of the removal corners from the outer blister and the inner blister was able to be removed as intended without force. The functional test could not replicate the reported event. -medical records received and evaluation: no patient information was provided. There is no indication patient factors contributed to the reported event. -device history review: review of the device history records indicates devices were manufactured and accepted into final stock with no reported discrepancies. -complaint history review: there have been no other events for this lot. Conclusions: the exact cause of the event could not be determined because during the functional test the reported difficulty of removing the inner blister from the outer blister could not be replicated.

 
Event Description

The inner blister was stuck inside the outer blister and would not come loose.

 
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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-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer Contact
keyla colon
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key6118459
MDR Text Key60871334
Report Number0002249697-2016-03730
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 COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/20/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/21/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number5515-F-402
Device LOT NumberV4GUWHHZ
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/16/2016
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/21/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/12/2016
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: 11/21/2016 Patient Sequence Number: 1
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