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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKNOWN; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
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SMITH & NEPHEW, INC. UNKNOWN; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL Back to Search Results
Device Problem Material Integrity Problem (2978)
Patient Problems Unspecified Infection (1930); Disability (2371)
Event Date 11/01/2016
Event Type  Injury  
Event Description
It was reported a revision hip surgery was performed after "the hip part broke while walking in a parking lot." patient could no longer bear weight.The hip components were removed and the surgeon told the patient there were pool pockets of fluid in his hip, infection, and metallosis.The patient stated he was wheelchair bound because no components were implanted and that he is permanently disabled.
 
Manufacturer Narrative
Please review attached for the investigation results.(b)(4).
 
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Brand Name
UNKNOWN
Type of Device
PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
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
MDR Report Key6641146
MDR Text Key77563320
Report Number1020279-2017-00425
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 company representative,consum
Reporter Occupation Patient
Type of Report Initial,Followup
Report Date 10/03/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/14/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received06/12/2017
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; Disability;
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