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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HIP IMPLANT; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
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SMITH & NEPHEW, INC. HIP IMPLANT; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL Back to Search Results
Device Problem Loose or Intermittent Connection (1371)
Patient Problem Pain (1994)
Event Date 01/23/2016
Event Type  Injury  
Event Description
It was reported that on 2017 veralist product failed.Device did not adhere to the bone structure, moved, and caused loosening and pain on the left hip.Further information is unknown.A quantity of 5 hip replacements were performed, it is unknown to which hip belongs each one.
 
Manufacturer Narrative
The associated complaint devices were not returned.A clinical evaluation was conducted and without the requested clinical information a thorough medical investigation cannot be rendered.Should any additional clinical information be provided this complaint will be re-evaluated.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.
 
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Brand Name
HIP IMPLANT
Type of Device
PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key8663527
MDR Text Key146823260
Report Number1020279-2019-02164
Device Sequence Number1
Product Code JDH
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup
Report Date 10/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/03/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Date Manufacturer Received05/13/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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