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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC.; HIP PROSTHESIS
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SMITH & NEPHEW, INC.; HIP PROSTHESIS Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pain (1994)
Event Date 12/08/2015
Event Type  Injury  
Manufacturer Narrative
Customer indicated that there is no product/device to be returned for investigation analysis.
 
Event Description
It was reported that a left hip revision surgery was performed due to pain and possible loosening of the implant.After the surgery, the surgeon stated he did not believe the stem was loose.
 
Manufacturer Narrative
The associated complaint device was not returned.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.
 
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Type of Device
HIP PROSTHESIS
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
robert rust
1450 brooks road
memphis, TN 38116
9013991624
MDR Report Key5330883
MDR Text Key34521177
Report Number1020279-2015-00896
Device Sequence Number1
Product Code JDH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/08/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/08/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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