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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 20 DEG XLPE ACET LNR 32MM X 50MM PRSTHSS, HIP,SMI-CNSTRIND, UNCMNTD, MTL/PLYMR, POROUS
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SMITH & NEPHEW, INC. R3 20 DEG XLPE ACET LNR 32MM X 50MM PRSTHSS, HIP,SMI-CNSTRIND, UNCMNTD, MTL/PLYMR, POROUS Back to Search Results
Model Number 71337650
Device Problem Connection Problem (2900)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/29/2019
Event Type  malfunction  
Event Description
It was reported that during surgery the outer cup was implanted and the liner cannot be locked. Another cup and liner were used to complete the surgery. Two hours of delay reported.
 
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Brand NameR3 20 DEG XLPE ACET LNR 32MM X 50MM
Type of DevicePRSTHSS, HIP,SMI-CNSTRIND, UNCMNTD, MTL/PLYMR, POROUS
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
smith & nephew, inc.
1450 brooks road
MDR Report Key9372686
MDR Text Key168675034
Report Number1020279-2019-04151
Device Sequence Number1
Product Code MBL
Combination Product (y/n)N
Reporter Country CodeCH
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,Followup
Report Date 02/11/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/25/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number71337650
Device Catalogue Number71337650
Device Lot Number18MM06587
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/23/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/06/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/11/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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