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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 Component Falling (1105); Sticking (1597); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)
Event Date 07/19/2016
Event Type  Malfunction  
Manufacturer Narrative

The device remained implanted in the patient, however packaging was returned. When completed, the investigation results will be submitted in a supplemental report.

 
Event Description

During total knee procedure, nurse went to open one of the ist inner packages, implant stuck to plastic then scrub went to assist and knee pull component out which then fell on floor. Then nurse opened final sterile package and femoral knee stuck to rubber plastic, both scrub nurse and circulating nurse had to work to get the implant out.

 
Manufacturer Narrative

An event regarding packaging issue involving a triathlon ps fem component, cemented was reported. The event was not confirmed. Method & results: -device evaluation and results: the packaging box with a shrink wrap partially open, the outer blister and the inner blister were returned. The implant, ifu, package insert, tyvek lids of both the inner blister and outer blister, and the foam were not returned. However, there is evidence that there was a seal in the inner and outer blisters. The inner sterile packaging looks as if it was pushed inside out. -medical records received and evaluation: not performed as medical records were not provided for review. -device history review: a device history review confirmed all devices accepted into finished goods conformed to specification. -complaint history review: no other events were reported for the lot indicated. Conclusions: the exact cause of the event could not be determined because the packaging was returned without the implant, the tyvek lid and the foam. No further investigation for this event is possible at this time. If additional information becomes available, this investigation will be reopened.

 
Event Description

During total knee procedure, nurse went to open one of the ist inner packages, implant stuck to plastic then scrub went to assist and knee pull component out which then fell on floor. Then nurse opened final sterile package and femoral knee stuck to rubber plastic, both scrub nurse and circulating nurse had to work to get the implant 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-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer Contact
keyla colon
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key5879418
MDR Text Key53053815
Report Number0002249697-2016-02620
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 07/19/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/16/2016
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 NumberVEPUD
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/26/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/19/2016
Was Device Evaluated By Manufacturer? No
Date Device Manufactured07/14/2016
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: 08/16/2016 Patient Sequence Number: 1
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