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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. COCR 12/14 FEM HD 26 + 0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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SMITH & NEPHEW, INC. COCR 12/14 FEM HD 26 + 0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Back to Search Results
Catalog Number 71302600
Medical Device Problem Codes Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Failure of Implant (1924); Joint Dislocation (2374)
Date of Event 03/30/2017
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported a revision hip surgery was performed due to luxation.
 
Additional Manufacturer Narrative
(b)(4).
 
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Brand Name
COCR 12/14 FEM HD 26 + 0
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 Key6507732
Report Number1020279-2017-00282
Device Sequence Number19239348
Product Code LPH
UDI-Device Identifier03596010194077
UDI-Public03596010194077
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K963509
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 10/02/2017
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 Number71302600
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 03/30/2017
Supplement Date Received by Manufacturer03/30/2017
Initial Report FDA Received Date04/20/2017
Supplement Report FDA Received Date10/02/2017
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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