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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION PS OXIN FEM SZ4 LT; PRSTHSS,KNEE,PTLLFEMRTBL,SEMICNSTRND,CMNTD,PLYMERMETALPOLYMER
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SMITH & NEPHEW, INC. LEGION PS OXIN FEM SZ4 LT; PRSTHSS,KNEE,PTLLFEMRTBL,SEMICNSTRND,CMNTD,PLYMERMETALPOLYMER Back to Search Results
Catalog Number 71421214
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes Unspecified Infection (1930); Injury (2348)
Date of Event 10/09/2017
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to infection.
 
Additional Manufacturer Narrative
Please review attached for the investigation results.
 
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Brand Name
LEGION PS OXIN FEM SZ4 LT
Common Device Name
PRSTHSS,KNEE,PTLLFEMRTBL,SEMICNSTRND,CMNTD,PLYMERMETALPOLYMER
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key6982049
Report Number1020279-2017-00929
Device Sequence Number444215
Product Code JWH
UDI-Device Identifier00885556029121
UDI-Public00885556029121
Combination Product (Y/N)N
Initial Reporter CountryAS
PMA/510(K) Number
K043440
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2014
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 12/19/2017
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 Date12/08/2023
Device Catalogue Number71421214
Device Lot Number13MM07397
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 10/11/2017
Supplement Date Received by Manufacturer10/11/2017
Initial Report FDA Received Date10/26/2017
Supplement Report FDA Received Date12/19/2017
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; Other;
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