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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKNOWN FEMORAL HEAD; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
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SMITH & NEPHEW, INC. UNKNOWN FEMORAL HEAD; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Cyst(s) (1800); Pain (1994)
Event Date 10/30/2017
Event Type  Injury  
Event Description
It was reported the patient has had persistent difficulty and pain.Mri suggested a significant soft tissue component and cyst around that greater trochanter.The patient underwent a revision left total hip where the liner was exchanged and the femoral head was replaced, with debridement of a soft tissue component and drainage of cyst.
 
Manufacturer Narrative
[(b)(4)].
 
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Brand Name
UNKNOWN FEMORAL HEAD
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
markus poettker
1450 brooks road
memphis, TN 38116
MDR Report Key7038250
MDR Text Key92280404
Report Number1020279-2017-01038
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 consumer
Reporter Occupation Patient
Type of Report Initial,Followup
Report Date 02/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/16/2017
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? No
Date Manufacturer Received11/03/2017
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;
Patient Age70 YR
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