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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 0 DEG XLPE ACET LNR 36MM X 54MM PRSTHSS, HP, SM-CNSTRND, NCMNTD, MTL/PLYMR, PRS

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SMITH & NEPHEW, INC. R3 0 DEG XLPE ACET LNR 36MM X 54MM PRSTHSS, HP, SM-CNSTRND, NCMNTD, MTL/PLYMR, PRS Back to Search Results
Model Number 71332754
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Injury (2348)
Event Date 01/21/2020
Event Type  Injury  
Event Description
It was reported that revision surgery was performed due to primary coxarthrosis.
 
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Brand NameR3 0 DEG XLPE ACET LNR 36MM X 54MM
Type of DevicePRSTHSS, HP, SM-CNSTRND, NCMNTD, MTL/PLYMR, PRS
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
Manufacturer (Section G)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
Manufacturer Contact
sarah freestone
1450 brooks road
memphis, TN 38116
0447940038
MDR Report Key9666694
MDR Text Key177648441
Report Number1020279-2020-00465
Device Sequence Number1
Product Code MBL
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K113848
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/04/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/22/2020
Device Model Number71332754
Device Catalogue Number71332754
Device Lot Number10CM16073
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/29/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/25/2010
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/04/2020 Patient Sequence Number: 1
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