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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF ALL POLY 32ID 49OD XLPE; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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SMITH & NEPHEW, INC. REF ALL POLY 32ID 49OD XLPE; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Back to Search Results
Catalog Number 71358034
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 06/23/2016
Type of Reportable Event Serious Injury
Event or Problem Description
The patient presented with a preoperative diagnosis of infected right total hip arthroplasty.The patient underwent a removal of right total hip arthroplasty, placement of unipolar cement spacer.
 
Additional Manufacturer Narrative
The associated complaint device was not returned for evaluation.Please review attached for investigation results.(b)(4).
 
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Brand Name
REF ALL POLY 32ID 49OD XLPE
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 Key6790239
Report Number1020279-2017-00623
Device Sequence Number121140
Product Code LPH
UDI-Device Identifier03596010474247
UDI-Public03596010474247
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K002747
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2016
Reporter Type Manufacturer
Report Source company representative,consum
Initial Reporter Occupation Attorney
Type of Report Initial,Followup
Report Date (Section B) 11/20/2017
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 Expiration Date06/17/2025
Device Catalogue Number71358034
Device Lot Number15FT55135
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 07/14/2017
Supplement Date Received by Manufacturer07/14/2017
Initial Report FDA Received Date08/11/2017
Supplement Report FDA Received Date11/20/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 Yes
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age53 YR
Patient Weight76
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