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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 20 DEG XLPE LNR 40MM ID X 56OD; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
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SMITH & NEPHEW, INC. R3 20 DEG XLPE LNR 40MM ID X 56OD; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS Back to Search Results
Catalog Number 71338687
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code Injury (2348)
Date of Event 10/25/2016
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that patient had a revision surgery performed due to debilitating right hip pain and instability.Also, metallosis and reactive inflammatory fluid surrounding the hip joint were discovered.
 
Additional Manufacturer Narrative
This report has been identified as a duplicate report of 1020279-2018-01056.
 
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Brand Name
R3 20 DEG XLPE LNR 40MM ID X 56OD
Common Device Name
PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key7857946
Report Number1020279-2018-01752
Device Sequence Number16640915
Product Code MBL
UDI-Device Identifier00885556113189
UDI-Public00885556113189
Combination Product (Y/N)N
Initial Reporter StateMS
Initial Reporter CountryUS
PMA/510(K) Number
K093363
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2011
Device Explanted Year2016
Reporter Type Manufacturer
Report Source company representative,other
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date (Section B) 09/07/2018
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 Date12/14/2020
Device Catalogue Number71338687
Device Lot Number10MM11064
Initial Date Received by Manufacturer 08/09/2018
Supplement Date Received by Manufacturer08/09/2018
Initial Report FDA Received Date09/07/2018
Supplement Report FDA Received Date09/20/2018
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age72 YR
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