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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN CEMENT STEM10MMX120MM STRT; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAIND,CMNTD,POLYMR/METAL/POLYMR
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SMITH & NEPHEW, INC. LGN CEMENT STEM10MMX120MM STRT; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAIND,CMNTD,POLYMR/METAL/POLYMR Back to Search Results
Catalog Number 71424182
Medical Device Problem Code Fitting Problem (2183)
Health Effect - Clinical Codes Bone Fracture(s) (1870); Injury (2348)
Date of Event 12/07/2017
Type of Reportable Event Serious Injury
Event or Problem Description
When inserting the tibial implant cannot be fully seated.The tibia suffers a fissure and the surgery has a delay of 90 minutes.
 
Additional Manufacturer Narrative
(b)(4).
 
Event or Problem Description
Surgeon noted that outline of the stem does not correspond to the outline of the trial stem device.
 
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Brand Name
LGN CEMENT STEM10MMX120MM STRT
Common Device Name
PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAIND,CMNTD,POLYMR/METAL/POLYMR
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key7145746
Report Number1020279-2017-01338
Device Sequence Number1275542
Product Code JWH
UDI-Device Identifier03596010546999
UDI-Public03596010546999
Combination Product (Y/N)N
Initial Reporter CountrySZ
PMA/510(K) Number
K043440
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
Report Date (Section B) 03/19/2018
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 Expiration Date05/11/2026
Device Catalogue Number71424182
Device Lot Number16DSM0033A
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 12/07/2017
Supplement Date Received by Manufacturer12/07/2017
Initial Report FDA Received Date12/26/2017
Supplement Report FDA Received Date03/19/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
71434023/UNKNOWN
Outcome Attributed to Adverse Event Death; Hospitalization; Required Intervention;
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