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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SYN POR HO FEM COM SZ 12; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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SMITH & NEPHEW, INC. SYN POR HO FEM COM SZ 12; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Back to Search Results
Model Number 71306112
Health Effect - Clinical Code No Code Available (3191)
Date of Event 08/22/2017
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that patient underwent a revision of femoral stem which was loose and had subsided.The liner was exchanged and a new revision stem was placed with a new femoral head.
 
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
SYN POR HO FEM COM SZ 12
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 Key6816762
Report Number1020279-2017-00653
Device Sequence Number18864885
Product Code LPH
UDI-Device Identifier03596010291967
UDI-Public03596010291967
Combination Product (Y/N)N
Initial Reporter StateOH
Initial Reporter CountryUS
PMA/510(K) Number
K963509
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2012
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 Expiration Date03/30/2019
Device Model Number71306112
Device Catalogue Number71306112
Device Lot Number09DM00298
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 08/22/2017
Supplement Date Received by Manufacturer08/22/2017
Initial Report FDA Received Date08/24/2017
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
Concomitant Medical Products
and Therapy/Usage Dates
OXINIUM MODULAR HEAD 40MM,71342340/10JM14204; R3 DEGREE XLPE ACET LNR 40MM,71338679/10JM14204; TITANIUM MODULAR HEAD SLEEVE,71344247/10JM14204
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age73 YR
Patient Weight66
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