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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF SPHER HEAD SCREW 30MM PRSTHSIS,HIP,SMI-CNSTRND,UNCMNTD,MTAL/PLYMR,NN-PORS,CLICUM-PHSPHTE
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SMITH & NEPHEW, INC. REF SPHER HEAD SCREW 30MM PRSTHSIS,HIP,SMI-CNSTRND,UNCMNTD,MTAL/PLYMR,NN-PORS,CLICUM-PHSPHTE Back to Search Results
Catalog Number 71332530
Device Problems Calibration Problem (2890); Unintended Movement (3026)
Patient Problems No Consequences Or Impact To Patient (2199); Injury (2348)
Event Date 01/02/2019
Event Type  malfunction  
Event Description
It was reported that after a total hip replacement procedure, post operative film showed that the screw had gone completely through the shell. No delay reported. No revision surgery performed.
 
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Brand NameREF SPHER HEAD SCREW 30MM
Type of DevicePRSTHSIS,HIP,SMI-CNSTRND,UNCMNTD,MTAL/PLYMR,NN-PORS,CLICUM-PHSPHTE
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 Key8278440
MDR Text Key134116212
Report Number1020279-2019-00287
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K990666
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/25/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number71332530
Device Lot Number18FM08799
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/28/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/13/2018
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: 01/25/2019 Patient Sequence Number: 1
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