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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 CONST 56MM; PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED
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SMITH & NEPHEW, INC. R3 CONST 56MM; PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED Back to Search Results
Model Number 71339156
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes Injury (2348); Joint Dislocation (2374)
Date of Event 07/27/2017
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that the patient had a fall and a revision was performed for disassociation.Surgeon replaced the liner.
 
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Brand Name
R3 CONST 56MM
Common Device Name
PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key6800417
Report Number1020279-2017-00636
Device Sequence Number13732018
Product Code KWZ
UDI-Device Identifier00885556020470
UDI-Public(01)00885556020470(17)260207(10)16BM07740
Combination Product (Y/N)N
Initial Reporter StateGA
Initial Reporter CountryUS
PMA/510(K) Number
K083566
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 11/01/2017
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 Expiration Date02/07/2026
Device Model Number71339156
Device Catalogue Number71339156
Device Lot Number16BM07740
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer08/04/2017
Initial Date Received by Manufacturer 07/28/2017
Supplement Date Received by Manufacturer07/28/2017
Initial Report FDA Received Date08/17/2017
Supplement Report FDA Received Date11/01/2017
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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