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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3; HIP PROSTHESIS
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SMITH & NEPHEW, INC. R3; HIP PROSTHESIS Back to Search Results
Device Problem Device Slipped (1584)
Patient Problem No Code Available (3191)
Event Date 08/08/2007
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 left hip surgery was performed due to loosening of the cup.
 
Manufacturer Narrative
The associated complaint devices were not returned.Without the actual product involved, the complaint could not be confirmed and a root cause could not be determined with confidence.No lot number was provided; hence a review of manufacturing records could not be completed.No further actions are required at this time.
 
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Brand Name
R3
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 Key5300169
MDR Text Key33584421
Report Number1020279-2015-00864
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 04/05/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/15/2015
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 Age77 YR
Patient Weight70
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