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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION CR HI FLEX XLPE ISRT 1-2 10MM; PRSTHSS,KNEE,PATLOFEMRTIBIAL,SMICNSTRND,CMNTD,POLYMR/METAL/POLYMR
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SMITH & NEPHEW, INC. LEGION CR HI FLEX XLPE ISRT 1-2 10MM; PRSTHSS,KNEE,PATLOFEMRTIBIAL,SMICNSTRND,CMNTD,POLYMR/METAL/POLYMR Back to Search Results
Catalog Number 71453181
Medical Device Problem Code Unintended Movement (3026)
Health Effect - Clinical Codes Failure of Implant (1924); Pain (1994); Injury (2348)
Date of Event 08/16/2017
Type of Reportable Event Serious Injury
Event or Problem Description
Revision surgery was performed due to pain and disassociation.
 
Additional Manufacturer Narrative
Please review attached for the investigation results.
 
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Brand Name
LEGION CR HI FLEX XLPE ISRT 1-2 10MM
Common Device Name
PRSTHSS,KNEE,PATLOFEMRTIBIAL,SMICNSTRND,CMNTD,POLYMR/METAL/POLYMR
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key6880354
Report Number1020279-2017-00758
Device Sequence Number751151
Product Code JWH
UDI-Device Identifier00885556487242
UDI-Public00885556487242
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K071071
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 11/29/2017
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 Date05/26/2025
Device Catalogue Number71453181
Device Lot Number15EM19463
Was Device Available for Evaluation? Yes
Initial Date Received by Manufacturer 08/30/2017
Supplement Date Received by Manufacturer08/30/2017
Initial Report FDA Received Date09/20/2017
Supplement Report FDA Received Date11/29/2017
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;
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