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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRIAL REMOVAL HANDLE PROSTH, HIP, SEMI-CONSTRA, UNCEMENT, METAL/POLY, NON-POROUS, CALICUM-PHOSPHATE

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SMITH & NEPHEW, INC. TRIAL REMOVAL HANDLE PROSTH, HIP, SEMI-CONSTRA, UNCEMENT, METAL/POLY, NON-POROUS, CALICUM-PHOSPHATE Back to Search Results
Model Number 71360920
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/02/2020
Event Type  malfunction  
Event Description
It was reported that during total hip replacement the trial removal handle broke in case. No delay. Surgery was completed with original device. Patient was not affected by incident.
 
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Brand NameTRIAL REMOVAL HANDLE
Type of DevicePROSTH, HIP, SEMI-CONSTRA, UNCEMENT, METAL/POLY, NON-POROUS, CALICUM-PHOSPHATE
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
Manufacturer (Section G)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
Manufacturer Contact
holly topping
1450 brooks road
memphis, TN 38116
MDR Report Key10763277
MDR Text Key213896415
Report Number1020279-2020-05952
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K113789
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/25/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number71360920
Device Catalogue Number71360920
Device Lot Number12GSY0002
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/06/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/22/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/30/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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