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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM MODULAR FEMORAL HEAD; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
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SMITH & NEPHEW, INC. OXINIUM MODULAR FEMORAL HEAD; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problem Pain (1994)
Event Date 02/09/2016
Event Type  Injury  
Event Description
It was reported that the patient had persistent back and leg pain that failed to improve with non-operative management.He underwent uneventful surgery and routine post op care.
 
Manufacturer Narrative
The associated complaint devices were not returned.A clinical evaluation was conducted and the clinical information provided, of the ¿osteolytic/metallosis and synovial reaction¿ may be consistent with a reaction to metal debris.However, the source and the root cause cannot be determined with the available documentation.The root cause of the dislocations cannot be concluded based on the information provided.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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Brand Name
OXINIUM MODULAR 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
MDR Report Key8864331
MDR Text Key153377470
Report Number1020279-2019-02924
Device Sequence Number1
Product Code JDH
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup,Followup
Report Date 09/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/06/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Date Manufacturer Received09/24/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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