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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN XLPE DISHED ISRT SZ 3-4 11M; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER
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SMITH & NEPHEW, INC. LGN XLPE DISHED ISRT SZ 3-4 11M; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER Back to Search Results
Model Number 71453278
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Pain (1994)
Date of Event 05/17/2017
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that a revision surgery was reported for pain.A poly swap occurred.
 
Additional Manufacturer Narrative
The associated complaint devices were not returned for evaluation.
 
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Brand Name
LGN XLPE DISHED ISRT SZ 3-4 11M
Common Device Name
PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key6645048
Report Number1020279-2017-00433
Device Sequence Number19103144
Product Code JWH
UDI-Device Identifier00885556255698
UDI-Public00885556255698
Combination Product (Y/N)N
Initial Reporter CountrySF
PMA/510(K) Number
K071071
Number of Events Summarized1
Summary Report (Y/N)N
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 08/01/2017
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 Date08/09/2024
Device Model Number71453278
Device Catalogue Number71453278
Device Lot Number14HM07687
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 05/17/2017
Supplement Date Received by Manufacturer05/17/2017
Initial Report FDA Received Date06/15/2017
Supplement Report FDA Received Date08/01/2017
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;
Patient Age60 YR
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