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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII HA POROUS P/S FEM S6 LT FEMORAL COMPONENT

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SMITH & NEPHEW, INC. GII HA POROUS P/S FEM S6 LT FEMORAL COMPONENT Back to Search Results
Catalog Number 71931645
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Toxicity (2333)
Event Date 10/21/2015
Event Type  Injury  
Manufacturer Narrative

Customer indicated that there is no product/device to be returned for investigation analysis.

 
Event Description

It was reported that a revision left total knee resurfacing was performed. It was also noted that metallosis was seen and samples confirmed increased crco levels.

 
Manufacturer Narrative

The associated complaint device was not returned. Without the actual product involved, the complaint could not be confirmed and a root cause could not be determined with confidence. A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident. No further actions are required at this time.

 
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Brand NameGII HA POROUS P/S FEM S6 LT
Type of DeviceFEMORAL COMPONENT
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
Manufacturer (Section G)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
Manufacturer Contact
robert rust
1450 brooks road
memphis, TN 38116
9013991624
MDR Report Key5322003
MDR Text Key34198652
Report Number1020279-2015-00872
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeAS
PMA/PMN NumberK030612
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,U
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/05/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/23/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/16/2020
Device Catalogue Number71931645
Device LOT Number10EM03861A
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 Received12/02/2015
Was Device Evaluated By Manufacturer? No
Date Device Manufactured07/19/2010
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: 12/23/2015 Patient Sequence Number: 1
Treatment
(B)(4)
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