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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF THREE HOLE SHELL 50MM PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

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SMITH & NEPHEW, INC. REF THREE HOLE SHELL 50MM PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS Back to Search Results
Model Number 71336450
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 THREE HOLE SHELL 50MM
Type of DevicePROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, 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
1450 brooks road
memphis, TN 38116
0447940038
MDR Report Key9517163
MDR Text Key177211166
Report Number1020279-2019-04587
Device Sequence Number1
Product Code MBL
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K960094
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 Number71336450
Device Catalogue Number71336450
Device Lot Number19HM06387
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 Manufactured08/07/2019
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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