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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 CONST 60MM; PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL
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SMITH & NEPHEW, INC. R3 CONST 60MM; PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL Back to Search Results
Model Number 71339160
Medical Device Problem Code Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code No Information (3190)
Date of Event 05/31/2017
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported a revision of the constrained liner was performed due to dislocation.
 
Additional Manufacturer Narrative
The associated complaint devices were not returned for evalulation.Please see attached file for our results of investigation.(b)(4).
 
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Brand Name
R3 CONST 60MM
Common Device Name
PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key6658322
Report Number1020279-2017-00468
Device Sequence Number11205403
Product Code KWZ
UDI-Device Identifier00885556021330
UDI-Public00885556021330
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K083566
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative,health
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 Model Number71339160
Device Catalogue Number71339160
Was Device Available for Evaluation? Yes
Initial Date Received by Manufacturer 05/31/2017
Supplement Date Received by Manufacturer05/31/2017
Initial Report FDA Received Date06/21/2017
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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