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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. STEM IMPACTOR ROD PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

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SMITH & NEPHEW, INC. STEM IMPACTOR ROD PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED Back to Search Results
Catalog Number 71364011
Device Problem Break
Event Date 06/18/2019
Event Type  Malfunction  
Event Description

It was reported that during a revision procedure, pummel tip broke while trying to remove the anthology stem. No delay. No confirmation of backup has been received. No injury or impact to patient reported.

 
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Brand NameSTEM IMPACTOR ROD
Type of DevicePROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
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 Key8746916
Report Number1020279-2019-02596
Device Sequence Number1
Product CodeJDI
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 07/30/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/30/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number71364011
Device LOT Number09JM69371
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/05/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/18/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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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