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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF LNR 28X50-52 20 DEG SZ E; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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SMITH & NEPHEW, INC. REF LNR 28X50-52 20 DEG SZ E; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Back to Search Results
Model Number 71742850
Medical Device Problem Code Positioning Problem (3009)
Health Effect - Clinical Codes Failure of Implant (1924); Injury (2348)
Date of Event 05/29/2017
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that patient underwent a revision thr with exchange of poly liner & femoral head due to eccentric head position, poly wear and large effusion around hip joint.
 
Additional Manufacturer Narrative
Please review attached for investigation results.
 
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Brand Name
REF LNR 28X50-52 20 DEG SZ E
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 Key6656441
Report Number1020279-2017-00458
Device Sequence Number16513482
Product Code LPH
UDI-Device Identifier03596010232267
UDI-Public03596010232267
Combination Product (Y/N)N
Initial Reporter CountryAS
PMA/510(K) Number
K932755
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2003
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date (Section B) 10/05/2017
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 Model Number71742850
Device Catalogue Number71742850
Device Lot Number03AM00663
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/29/2017
Initial Date Received by Manufacturer 05/30/2017
Supplement Date Received by Manufacturer06/29/2017
06/29/2017
Initial Report FDA Received Date06/21/2017
Supplement Report FDA Received Date07/04/2017
10/05/2017
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
COCR 12/14 FEM HD 28 + 4, (B)(4)
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age82 YR
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