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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ANTHOLOGY INSERTER POSTER HARD PRSTHSS, HIP, SMI-COSTRND, METALCERMICPLYMER CMNTD OR NON-POROUS, UNCMNTD

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SMITH & NEPHEW, INC. ANTHOLOGY INSERTER POSTER HARD PRSTHSS, HIP, SMI-COSTRND, METALCERMICPLYMER CMNTD OR NON-POROUS, UNCMNTD Back to Search Results
Catalog Number 71365705
Device Problems Break (1069); Loose or Intermittent Connection (1371)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/19/2018
Event Type  Malfunction  
Event Description

Item broke during surgery. Used an identical backup device to complete surgery. Surgery time was not extended more than 30 min. The surgeon does not fault the device. The patient or surgical procedure was not affected in any way due to the problem. No broken pieces were left inside the patient.

 
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Brand NameANTHOLOGY INSERTER POSTER HARD
Type of DevicePRSTHSS, HIP, SMI-COSTRND, METALCERMICPLYMER CMNTD OR NON-POROUS, UNCMNTD
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
101 hessle road
hull hu3 2bn
UK  
MDR Report Key7489398
MDR Text Key107453298
Report Number1020279-2018-00870
Device Sequence Number1
Product Code LZO
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK113789
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/15/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/05/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device Catalogue Number71365705
Device LOT Number12JM08888
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/27/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/19/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/17/2012
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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