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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOLOX DELTA HEAD 32 MM 12/14 S / +0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER
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SMITH & NEPHEW, INC. BIOLOX DELTA HEAD 32 MM 12/14 S / +0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER Back to Search Results
Catalog Number 76539160
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Pain (1994)
Date of Event 02/16/2017
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported the patient underwent a right hip steroid injection due to pain.
 
Additional Manufacturer Narrative
(b)(4).
 
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Brand Name
BIOLOX DELTA HEAD 32 MM 12/14 S / +0
Common Device Name
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key6531894
Report Number1020279-2017-00307
Device Sequence Number18833744
Product Code LZO
UDI-Device Identifier03596010566928
UDI-Public03596010566928
Combination Product (Y/N)N
Initial Reporter StateOH
Initial Reporter CountryUS
PMA/510(K) Number
K083762
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 10/03/2017
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 Date06/16/2024
Device Catalogue Number76539160
Device Lot Number14FT43192
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 04/06/2017
Supplement Date Received by Manufacturer04/06/2017
Initial Report FDA Received Date04/28/2017
Supplement Report FDA Received Date10/03/2017
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
LINER PART# 71337948 LOT# 08KM13639; SHELL PART# 71335548 LOT# 14MM00540; STEM PART # 71357005 LOT# 15KM16940
Outcome Attributed to Adverse Event Required Intervention;
Patient Age47 YR
Patient Weight63
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