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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII POST REF A/P BLK SZ 6 PRSTHSIS,KNEE,PATLLO/FMORTIBIL,SMICSTRAIND,UNCMNTD,PORS,COATD,POLYMR/METL/POLYMR

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SMITH & NEPHEW, INC. GII POST REF A/P BLK SZ 6 PRSTHSIS,KNEE,PATLLO/FMORTIBIL,SMICSTRAIND,UNCMNTD,PORS,COATD,POLYMR/METL/POLYMR Back to Search Results
Catalog Number 71440820
Device Problems Entrapment of Device (1212); Detachment of Device or Device Component (2907)
Patient Problem Foreign Body In Patient (2687)
Event Date 09/10/2018
Event Type  Injury  
Event Description

It was reported that during a case, the product in question was being placed on the patient and impacted. The bone spike detached from the block and was left in the patient. The surgeon used an osteotome to remove some bone around the spike so it could be removed.

 
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Brand NameGII POST REF A/P BLK SZ 6
Type of DevicePRSTHSIS,KNEE,PATLLO/FMORTIBIL,SMICSTRAIND,UNCMNTD,PORS,COATD,POLYMR/METL/POLYMR
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks rd.
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
MDR Report Key7931820
MDR Text Key122557682
Report Number1020279-2018-01954
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUK
PMA/PMN NumberK121393
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 02/05/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/03/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number71440820
Device LOT Number09EM02889
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/10/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/05/2009
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: 10/03/2018 Patient Sequence Number: 1
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