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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG HIP REPLACEMENT DEVICE PROSTHESIS, HIP, HEMI - FEMORAL, METAL / POLYMER, CEMENTED OR UNCEMENTED

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SMITH & NEPHEW ORTHOPAEDICS AG HIP REPLACEMENT DEVICE PROSTHESIS, HIP, HEMI - FEMORAL, METAL / POLYMER, CEMENTED OR UNCEMENTED Back to Search Results
Catalog Number 71335552
Device Problem Noise, Audible (3273)
Patient Problems Pain (1994); Toxicity (2333); Cognitive Changes (2551)
Event Date 03/31/2011
Event Type  Injury  
Event Description
Left hip replacement with smith & nephew device causing metal-on-metal toxic side effects. Chromium and cobalt elevated levels which indicated replacement device surgery as soon as possible. Experiencing cognitive decline and pain. Since the beginning, a clicking noise has always been present in the left hip.
 
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Brand NameHIP REPLACEMENT DEVICE
Type of DevicePROSTHESIS, HIP, HEMI - FEMORAL, METAL / POLYMER, CEMENTED OR UNCEMENTED
Manufacturer (Section D)
SMITH & NEPHEW ORTHOPAEDICS AG
MDR Report Key8186264
MDR Text Key131328084
Report NumberMW5082360
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Unknown
Type of Report Initial
Report Date 12/18/2018
3 Devices were Involved in the Event: 1   2   3  
1 Patient was Involved in the Event
Date FDA Received12/19/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number71335552
Device Lot Number10NM16479
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 12/19/2018 Patient Sequence Number: 1
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