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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GENESIS II SPC P/S HOUS COLLET S 3-8 PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS

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SMITH & NEPHEW, INC. GENESIS II SPC P/S HOUS COLLET S 3-8 PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS Back to Search Results
Catalog Number 71440001
Device Problems Component Falling (1105); Material Separation (1562)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/10/2016
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported that the collet fell apart during a primary tha while placing on the femoral trial. The surgery was delayed more than 30 minutes.

 
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Brand NameGENESIS II SPC P/S HOUS COLLET S 3-8
Type of DevicePROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS
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
claudia odoy
1450 brooks road
memphis, TN 38116
0416283206
MDR Report Key6031300
MDR Text Key57498969
Report Number1020279-2016-00791
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK121393
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/10/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/14/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number71440001
Device LOT Number09KM00564
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/19/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/10/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/01/2009
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 10/14/2016 Patient Sequence Number: 1
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