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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII FEMORAL IMPACTOR PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

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SMITH & NEPHEW, INC. GII FEMORAL IMPACTOR PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS Back to Search Results
Catalog Number 71440190
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/11/2019
Event Type  malfunction  
Event Description
After the femoral legion implant was impacted onto the femur, a small piece of carbon fiber was noticed which had fallen off the impactor. The impactor was observed and small amounts of material had been chipped off the edges. This is most likely a wear and tear problem due to excessive autoclave amounts.
 
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Brand NameGII FEMORAL IMPACTOR
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 Key8977941
MDR Text Key157035466
Report Number1020279-2019-03321
Device Sequence Number1
Product Code MBL
Combination Product (y/n)N
Reporter Country CodeSF
PMA/PMN Number
EXEMPT
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 11/05/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/09/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number71440190
Device Lot Number18ESM0022
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 Received08/11/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/25/2018
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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