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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RF LNR 28X62-64 20DEG L+4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
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SMITH & NEPHEW, INC. RF LNR 28X62-64 20DEG L+4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED Back to Search Results
Catalog Number 71332462
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes Injury (2348); Osteolysis (2377)
Date of Event 09/19/2017
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to polyethylene wear with osteolysis.
 
Additional Manufacturer Narrative
The associated complaint device was not returned for evaluation.Please see attached for the results of our investigation.(b)(4).
 
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Brand Name
RF LNR 28X62-64 20DEG L+4
Common Device Name
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key6908536
Report Number1020279-2017-00814
Device Sequence Number750813
Product Code JDI
UDI-Device Identifier03596010197221
UDI-Public03596010197221
Combination Product (Y/N)N
Initial Reporter CountryAS
PMA/510(K) Number
K932755
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 03/08/2018
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 No Information
Device Catalogue Number71332462
Device Lot Number70102037
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 09/19/2017
Supplement Date Received by Manufacturer09/19/2017
Initial Report FDA Received Date10/02/2017
Supplement Report FDA Received Date03/08/2018
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
(B)(4); (B)(4)
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age84 YR
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