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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 Device Operates Differently Than Expected (2913)
Patient Problem No Code Available (3191)
Event Date 07/23/2012
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 revision right hip surgery was performed to replace the stem and acetabular cup for unspecified reasons.
 
Manufacturer Narrative
Examination was not possible, as the device was not returned.The investigation was limited to the information provided.The investigation could not draw any conclusions about the reported event with the clinical details provided.A review of the device history record was not possible due to a lot number not being provided.No further investigation is warranted 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 Key5314432
MDR Text Key33996814
Report Number1020279-2015-00867
Device Sequence Number1
Product Code JDH
Combination Product (y/n)N
Reporter Country CodeBE
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,s
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 11/30/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2015
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 Received11/30/2015
Was Device Evaluated by Manufacturer? No
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;
Patient Age78 YR
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