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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR FEM COMP #4 R-CEM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

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STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR FEM COMP #4 R-CEM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 5510F402
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problems Cyst(s) (1800); Edema (1820); Injury (2348)
Event Date 02/25/2016
Event Type  Injury  
Manufacturer Narrative

When completed, the investigation results will be submitted in a supplemental report.

 
Event Description

Cyst on femur. Replaced triathlon components with gmrs/mrh components.

 
Manufacturer Narrative

An event regarding cyst on femur resulting in revision surgery involving a triathlon femoral component was reported. The event was confirmed. Method & results: device evaluation and results: visual inspection of the returned femoral component has bone cement still adhered to the inferior surface with evidence of bone ingrowth throughout. There is also a peg-like formation of cement which would indicate a void was present in the femur into which the bone cement filled. The superior condyle surfaces have some mild abrasive wear that is consistent with in vivo use as well as some explantation damage. The device is otherwise unremarkable. Medical records received and evaluation: insufficient medical records were received for review with a clinical consultant. Post event x-rays would be required to probably solve this case. Device history review: dhr review for the reported lot determined that the device was manufactured and packed to specification. Complaint history review: complaint history review confirmed that there have been no other similar events for the reported lot. Conclusion: it is reported that the patient had a cyst on the femur and revision surgery took place whereby the reported triathlon devices were revised to a gmrs/mrh knee system. The exact cause of the event could not be determined as insufficient information was provided. Further information such as post event x-rays are needed to complete the investigation for determining a root cause. No further investigation is possible at this time. If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

 
Event Description

Cyst on femur. Replaced triathlon components with gmrs/mrh components.

 
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Brand NameTRIATHLON CR FEM COMP #4 R-CEM
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-LIMERICK
raheen business park
limerick NJ NA
Manufacturer Contact
keyla colon
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key5508342
MDR Text Key40609534
Report Number0002249697-2016-00903
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 02/25/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/17/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/30/2012
Device Catalogue Number5510F402
Device LOT NumberSEAEH
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/18/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/06/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/07/2007
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: 03/17/2016 Patient Sequence Number: 1
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