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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HIP IMPLANT; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
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SMITH & NEPHEW, INC. HIP IMPLANT; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL Back to Search Results
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem Injury (2348)
Event Date 02/25/2019
Event Type  Injury  
Event Description
It was reported that a revision surgery was performed due to stem sinking and dislocation.
 
Manufacturer Narrative
The associated complaint device was not returned.The medical investigation concluded that it was communicated via email that no relevant supporting clinical information will be provided, and there is no report of the patient's current condition.Therefore, based on insufficient information, no further clinical assessment can be performed at this time.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, the complaint can be re-opened.No further actions are being taken at this time.
 
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Brand Name
HIP IMPLANT
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 Key8468310
MDR Text Key140420933
Report Number1020279-2019-01304
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 foreign,health professional,u
Type of Report Initial,Followup
Report Date 10/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Initial Date Manufacturer Received 03/12/2019
Initial Date FDA Received04/01/2019
Supplement Dates Manufacturer Received03/12/2019
Supplement Dates FDA Received10/08/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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