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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 CONST 52MM; PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER
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SMITH & NEPHEW, INC. R3 CONST 52MM; PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER Back to Search Results
Catalog Number 71339152
Medical Device Problem Code Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code Injury (2348)
Date of Event 01/10/2019
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that revision surgery was performed on the patient due to a dislocation.No additional information specified.
 
Additional Manufacturer Narrative
The associated complaint device was not returned.The clinical/medical team concluded, without supporting clinical/medical documents a thorough investigation cannot be performed.Should information become available this complaint can be re assessed.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re opened.We consider this investigation closed.
 
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Brand Name
R3 CONST 52MM
Common Device Name
PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key8298455
Report Number1020279-2019-00379
Device Sequence Number1947344
Product Code KWZ
UDI-Device Identifier00885556022443
UDI-Public00885556022443
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K083566
Number of Events Summarized1
Summary Report (Y/N)N
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 06/13/2019
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 Number71339152
Initial Date Received by Manufacturer 01/10/2019
Supplement Date Received by Manufacturer01/10/2019
Initial Report FDA Received Date02/01/2019
Supplement Report FDA Received Date06/13/2019
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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