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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GEN II CEMENTED TIBIAL B/PLATE SZ 7 LEFT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
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SMITH & NEPHEW, INC. GEN II CEMENTED TIBIAL B/PLATE SZ 7 LEFT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL Back to Search Results
Catalog Number 71420172
Medical Device Problem Code Loose or Intermittent Connection (1371)
Health Effect - Clinical Code Joint Dislocation (2374)
Date of Event 01/11/2018
Type of Reportable Event Serious Injury
Event or Problem Description
Tibial loosening, the old tibia was completely loose and removed.A quads tendon snip was performed for better access.Surgeon chose to use a 22 long tibial cone.He also cemented a 120mm stem in with a size 6 tibia and 18mm insert.
 
Additional Manufacturer Narrative
Please review attached for the investigation results.(b)(4).
 
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Brand Name
GEN II CEMENTED TIBIAL B/PLATE SZ 7 LEFT
Common Device Name
PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key7224080
Report Number1020279-2018-00078
Device Sequence Number1016072
Product Code JWH
UDI-Device Identifier03596010206299
UDI-Public03596010206299
Combination Product (Y/N)N
PMA/510(K) Number
K951987
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2013
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 03/14/2018
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 No Information
Device Catalogue Number71420172
Device Lot Number12KT24752
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 01/11/2018
Supplement Date Received by Manufacturer01/11/2018
Initial Report FDA Received Date01/29/2018
Supplement Report FDA Received Date03/14/2018
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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