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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RF ACET MH SZ 50 E; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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SMITH & NEPHEW, INC. RF ACET MH SZ 50 E; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Back to Search Results
Catalog Number 71335150
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code Injury (2348)
Date of Event 04/24/2017
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported a revision hip surgery was performed for unspecified reasons.
 
Additional Manufacturer Narrative
Device was not evaluted due to the actual device was not returned for investigation.Please see investigation summary attached.(b)(4).
 
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Brand Name
RF ACET MH SZ 50 E
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 Key6577040
Report Number1020279-2017-00351
Device Sequence Number11008138
Product Code LPH
UDI-Device Identifier03596010000781
UDI-Public03596010000781
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K932755
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2008
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 09/29/2017
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 No Information
Device Catalogue Number71335150
Initial Date Received by Manufacturer 04/24/2017
Supplement Date Received by Manufacturer04/24/2017
Initial Report FDA Received Date05/18/2017
Supplement Report FDA Received Date09/29/2017
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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