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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION PS OXIN FEM SZ6 LT; PRSTHSS,KNE,PTLLFMRTBL,SMCNSTRND,CMNTD,PLYMRMTLPLYMR
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SMITH & NEPHEW, INC. LEGION PS OXIN FEM SZ6 LT; PRSTHSS,KNE,PTLLFMRTBL,SMCNSTRND,CMNTD,PLYMRMTLPLYMR Back to Search Results
Catalog Number 71421216
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Injury (2348)
Date of Event 02/07/2018
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to faulty cement and mechanism.
 
Additional Manufacturer Narrative
Additional information received, identified that this event should be re-evaluated for mdr reporting.The reassessment determined that the issue does not meet the threshold for reporting and is a non-reportable event.This report was made based upon information which smith & nephew had not been able to investigate or verify prior to the required reporting date.
 
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Brand Name
LEGION PS OXIN FEM SZ6 LT
Common Device Name
PRSTHSS,KNE,PTLLFMRTBL,SMCNSTRND,CMNTD,PLYMRMTLPLYMR
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key7494730
Report Number1020279-2018-00896
Device Sequence Number1314061
Product Code JWH
UDI-Device Identifier00885556030059
UDI-Public00885556030059
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K043440
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2014
Device Explanted Year2018
Reporter Type Manufacturer
Report Source consumer
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 05/24/2018
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 Physician
Device Catalogue Number71421216
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 05/04/2018
Supplement Date Received by Manufacturer05/04/2018
Initial Report FDA Received Date05/08/2018
Supplement Report FDA Received Date05/24/2018
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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