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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 Fracture (1260)
Health Effect - Clinical Code Injury (2348)
Date of Event 05/08/2019
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported a revision surgery to replace cracked cup and remove the broken constrained liner.
 
Additional Manufacturer Narrative
The associated complaint device was not returned.The medical investigation concluded that, without the requested clinical information, a thorough medical investigation cannot be rendered.Should any additional clinical information be provided these complaints will be re-evaluated.Without the actual product involved and/ or product information, our investigation cannot proceed.If the device or new information is received in the future, these complaints can be re-opened.No further actions are being taken at this time.
 
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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 Key9073622
Report Number1020279-2019-03400
Device Sequence Number13890565
Product Code KWZ
UDI-Device Identifier00885556022443
UDI-Public00885556022443
Combination Product (Y/N)N
Initial Reporter StateNV
Initial Reporter CountryUS
PMA/510(K) Number
K083566
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 11/28/2019
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 08/19/2019
Supplement Date Received by Manufacturer08/19/2019
Initial Report FDA Received Date09/16/2019
Supplement Report FDA Received Date11/28/2019
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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