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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII ARTICULAR INSERTER/EXTRACT PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED

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SMITH & NEPHEW, INC. GII ARTICULAR INSERTER/EXTRACT PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED Back to Search Results
Catalog Number 71440194
Device Problem Fracture (1260)
Patient Problems Injury (2348); Device Embedded In Tissue or Plaque (3165)
Event Date 11/16/2017
Event Type  Injury  
Manufacturer Narrative

The 510k's associated with implanted devices: k951987, k032295, k060742.

 
Event Description

It was reported the tip of the instrument broke during surgery and was left in the patient. The patient had to return for an additional surgery to remove the piece.

 
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Brand NameGII ARTICULAR INSERTER/EXTRACT
Type of DevicePROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED
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
markus poettker
1450 brooks road
memphis, TN 38116
MDR Report Key7260844
MDR Text Key99613015
Report Number1020279-2018-00140
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeGM
PMA/PMN NumberK121393
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,O
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/13/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/09/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number71440194
Device LOT Number14DM20420
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/06/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/18/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/28/2014
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 02/09/2018 Patient Sequence Number: 1
Treatment
GENESIS II INSERT 71421508/17ET86698; GENESIS II TIBIA SHAFT 76547001/17ET87972; GENESIS II TIBIAL BASE 71420166/G1708700; LEGION FEMORAL COMPONENT 71423225/17EM10411
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