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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF LNR 28ID 20 DEG SZ D; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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SMITH & NEPHEW, INC. REF LNR 28ID 20 DEG SZ D; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Back to Search Results
Catalog Number 71742846
Medical Device Problem Code Degraded (1153)
Health Effect - Clinical Codes Failure of Implant (1924); No Code Available (3191)
Date of Event 05/03/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Is an approximation since only the year of the implantation surgery was communicated.
 
Event or Problem Description
It was reported that patient underwent a revision surgery with replacement of liner due to significant wear.Same size liner was implanted.
 
Additional Manufacturer Narrative
The associated complaint device was not returned for evaluation.Please see attached for the results of our investigation.
 
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Brand Name
REF LNR 28ID 20 DEG SZ D
Common Device Name
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key6603954
Report Number1020279-2017-00385
Device Sequence Number18989487
Product Code LPH
UDI-Device Identifier03596010232250
UDI-Public03596010232250
Combination Product (Y/N)N
Initial Reporter StateOH
Initial Reporter CountryUS
PMA/510(K) Number
K932755
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2001
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date (Section B) 10/04/2017
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 Catalogue Number71742846
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 05/03/2017
Supplement Date Received by Manufacturer05/03/2017
05/03/2017
Initial Report FDA Received Date06/01/2017
Supplement Report FDA Received Date10/04/2017
10/04/2017
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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