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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF SPHER HEAD SCREW 25MM PROST, HIP, SEMI-CNSTRAIND UNCEMENTED, MET/POLY, NON-PORS, CALICUM-PHSPHT

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SMITH & NEPHEW, INC. REF SPHER HEAD SCREW 25MM PROST, HIP, SEMI-CNSTRAIND UNCEMENTED, MET/POLY, NON-PORS, CALICUM-PHSPHT Back to Search Results
Model Number 71332525
Device Problem Misconnection (1399)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/26/2019
Event Type  malfunction  
Event Description
It was reported that during a thr surgery, the doctor prepared acetabulum and took a trial of cup size 50. It was good and fixed well so he took the original reflection shell and it fixed well. He then put a 25mm screw for better fixation, then fixed liner for 32 mm head. Later he prepared the femur fix stem and took trial for the head and reduced the hip joint. When he dislocated the hip to put the original head reflection shell, the liner came out and the screw remained inside the bone (it was later removed). He tried to fix it again but did not succeed and then he took size 54 mm. This caused a delay of 30 minutes to an hour.
 
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Brand NameREF SPHER HEAD SCREW 25MM
Type of DevicePROST, HIP, SEMI-CNSTRAIND UNCEMENTED, MET/POLY, NON-PORS, CALICUM-PHSPHT
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 Key9517190
MDR Text Key177213770
Report Number1020279-2019-04588
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K990666
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/12/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/24/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number71332525
Device Catalogue Number71332525
Device Lot Number19EM07769
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 Received03/09/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/09/2019
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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