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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 Insufficient Information (3190)
Patient Problem Pain (1994)
Event Type  Injury  
Event Description
It was reported that after primary thr patient had chronic pain when sitting.Has been through different treatments for pain such as nerve ablations, caudal blocks, steroid injections and other medications.Revision surgeries were suggested by different physicians but patient doesn't agree because of the long recovery.
 
Manufacturer Narrative
The associated complaint device was not returned for evaluation.Our clinical/medical team concluded: there is not sufficient relevant clinical information to conduct a thorough clinical analysis of the reported issue, after three attempts were made to obtain information.Additionally, the product is not available for return.Therefore, no further clinical assessment is warranted at this time.Should additional information be provided, the clinical/medical investigation task will be re-opened.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.We consider this investigation closed.
 
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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 Key8370864
MDR Text Key137167609
Report Number1020279-2019-00820
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
Report Date 06/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/26/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Date Manufacturer Received02/04/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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