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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII OXINIUM FEM SIZE 5 LEFT; PRSTHESIS HIP SEMI-CNSTIND MTAL/CRAMIC/POLY CMNTD O NONPOROUS UNCMNTD
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SMITH & NEPHEW, INC. GII OXINIUM FEM SIZE 5 LEFT; PRSTHESIS HIP SEMI-CNSTIND MTAL/CRAMIC/POLY CMNTD O NONPOROUS UNCMNTD Back to Search Results
Catalog Number OR71420136
Health Effect - Clinical Code No Code Available (3191)
Date of Event 08/30/2017
Type of Reportable Event Serious Injury
Event or Problem Description
Revised a tka from (b)(6) 2006.The surgeon does not fault the devices.
 
Additional Manufacturer Narrative
The associated complaint device was not returned for evaluation.Please see attached for investigation results.(b)(4).
 
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Brand Name
GII OXINIUM FEM SIZE 5 LEFT
Common Device Name
PRSTHESIS HIP SEMI-CNSTIND MTAL/CRAMIC/POLY CMNTD O NONPOROUS UNCMNTD
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key6881516
Report Number1020279-2017-00772
Device Sequence Number13676004
Product Code LZO
UDI-Device Identifier03596010430151
UDI-Public03596010430151
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K021673
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2006
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 11/08/2017
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 NumberOR71420136
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Yes
Initial Date Received by Manufacturer 08/30/2017
Supplement Date Received by Manufacturer08/30/2017
Initial Report FDA Received Date09/20/2017
Supplement Report FDA Received Date11/08/2017
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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