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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OSCILLAT SAW BLADE 1.27MM FAN PWRPRO; PROSTH, KNEE, PATE/FEMOROTIBIAL, SEMI-CONST, UNCEM, PORO, COAT, POLY/METAL/POLY
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SMITH & NEPHEW, INC. OSCILLAT SAW BLADE 1.27MM FAN PWRPRO; PROSTH, KNEE, PATE/FEMOROTIBIAL, SEMI-CONST, UNCEM, PORO, COAT, POLY/METAL/POLY Back to Search Results
Model Number 71440365
Medical Device Problem Code Fracture (1260)
Health Effect - Clinical Code Injury (2348)
Date of Event 03/07/2019
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that during implant insertion, tibia resected & sized - 3 tibia; stem prep with 11 mm punch; size 3 legion porous tibial base plate and 18mm stem assembled; inserted 50% and fracture appeared in prox tibia; tibial implant removed and prox tibia assessed.
 
Additional Manufacturer Narrative
Correct part number, lot number, and udi number added.
 
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Brand Name
OSCILLAT SAW BLADE 1.27MM FAN PWRPRO
Common Device Name
PROSTH, KNEE, PATE/FEMOROTIBIAL, SEMI-CONST, UNCEM, PORO, COAT, POLY/METAL/POLY
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key8475263
Report Number1020279-2019-01322
Device Sequence Number19235416
Product Code MBH
UDI-Device Identifier03596010515728
UDI-Public03596010515728
Combination Product (Y/N)N
Initial Reporter CountryAS
PMA/510(K) Number
K121393
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date (Section B) 12/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Model Number71440365
Device Catalogue Number71501010
Device Lot Number18GTX0012
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 03/07/2019
Supplement Date Received by Manufacturer03/07/2019
11/25/2020
Initial Report FDA Received Date04/02/2019
Supplement Report FDA Received Date04/04/2019
12/04/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
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