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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR FEM COMP #7 R-CEM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C

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STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR FEM COMP #7 R-CEM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C Back to Search Results
Catalog Number 5510F702
Device Problems Component Falling (1105); Difficult to Remove (1528); Insufficient Information (3190)
Patient Problems No Patient Involvement (2645); No Information (3190)
Event Date 11/04/2015
Event Type  Malfunction  
Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer. Additional information has been requested but not provided. Should additional information become available it will be reported in a supplemental report upon completion of the investigation. Not returned to the manufacturer.

 
Event Description

It was reported that our circulating nurse dropped the secondary clear femoral packaging on the floor when opening the green and white box outer packaging. When she went to have dr (b)(6) remove the femur from the secondary clear packaging, they found it extremely difficult to peel out of the vacuum fitting clear innermost package. This occurred during a right knee case.

 
Manufacturer Narrative

An event regarding reported difficulty opening sterile inner packaging involving a triathlon femoral component was reported. The event was not confirmed. Method & results: -device evaluation and results: device evaluation was not possible as the packaging was not returned nor were photographs provided. -medical records received and evaluation: not performed as the event is related to a packaging issue and no adverse consequences were reported. -device history review: dhr review for the reported lot determined that the device was manufactured and packed to specification. -complaint history review: chr review determined that there were no similar events reported for the lot. Conclusions: the surgeon had difficulties removing the femoral component from the inner blister. Based on the limited information provided, the reported event cannot be confirmed. Device evaluation was not possible as the packaging was not returned nor were photographs provided for review. No further investigation for this event is possible. If additional information becomes available, this investigation will be reopened.

 
Event Description

It was reported that our circulating nurse dropped the secondary clear femoral packaging on the floor when opening the green and white box outer packaging. When she went to have dr (b)(6) remove the femur from the secondary clear packaging, they found it extremely difficult to peel out of the vacuum fitting clear innermost package. This occurred during a right knee case.

 
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Brand NameTRIATHLON CR FEM COMP #7 R-CEM
Type of DevicePROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C
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
keyla navedo
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key5248458
MDR Text Key32204312
Report Number0002249697-2015-04012
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 11/04/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/24/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/31/2020
Device Catalogue Number5510F702
Device LOT NumberABS7F
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/17/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/25/2015
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: 11/24/2015 Patient Sequence Number: 1
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