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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION PS OXIN FEM SZ5 RT; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMI-CONSTRAINED,CEMENTED,POLYMER/METAL/POLY
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SMITH & NEPHEW, INC. LEGION PS OXIN FEM SZ5 RT; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMI-CONSTRAINED,CEMENTED,POLYMER/METAL/POLY Back to Search Results
Catalog Number 71421205
Medical Device Problem Code Detachment Of Device Component (1104)
Health Effect - Clinical Code Injury (2348)
Date of Event 12/04/2017
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported a revision surgery of smith and nephew knee implants.
 
Additional Manufacturer Narrative
The associated complaint device was not returned for evaluation.[(b)(4)].
 
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Brand Name
LEGION PS OXIN FEM SZ5 RT
Common Device Name
PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMI-CONSTRAINED,CEMENTED,POLYMER/METAL/POLY
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key7134179
Report Number1020279-2017-01299
Device Sequence Number19160161
Product Code JWH
UDI-Device Identifier00885556030622
UDI-Public00885556030622
Combination Product (Y/N)N
Initial Reporter StateGA
Initial Reporter CountryUS
PMA/510(K) Number
K043440
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 03/15/2018
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 Health Professional
Device Expiration Date11/30/2024
Device Catalogue Number71421205
Device Lot Number14MM03177
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 12/04/2017
Supplement Date Received by Manufacturer12/04/2017
Initial Report FDA Received Date12/20/2017
Supplement Report FDA Received Date03/15/2018
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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