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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION CR OXIN FEM SZ5 RT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
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SMITH & NEPHEW, INC. LEGION CR OXIN FEM SZ5 RT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED Back to Search Results
Catalog Number 71421225
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes Failure of Implant (1924); Injury (2348); Joint Dislocation (2374)
Date of Event 07/14/2017
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that revision surgery was performed due to instability.
 
Additional Manufacturer Narrative
(b)(4).
 
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Brand Name
LEGION CR OXIN FEM SZ5 RT
Common Device Name
PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key6788696
Report Number1020279-2017-00617
Device Sequence Number13845057
Product Code JWH
UDI-Device Identifier00885556030424
UDI-Public00885556030424
Combination Product (Y/N)N
Initial Reporter CountryGM
PMA/510(K) Number
K043440
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 11/27/2017
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 Date03/17/2024
Device Catalogue Number71421225
Device Lot Number14CM13598
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/15/2017
Initial Date Received by Manufacturer 07/14/2017
Supplement Date Received by Manufacturer07/14/2017
Initial Report FDA Received Date08/11/2017
Supplement Report FDA Received Date11/27/2017
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
71420186-E1415328; 71453121-14BM16952
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age65 YR
Patient Weight90
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