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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HIP-DUMMY IMPLANT; PROSTHSIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, MTAL/POLYACETL
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SMITH & NEPHEW, INC. HIP-DUMMY IMPLANT; PROSTHSIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, MTAL/POLYACETL Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problem Joint Dislocation (2374)
Event Date 02/11/2020
Event Type  Injury  
Event Description
It was reported that the patient is complaining about a hip dislocation.No additional medical intervention has been performed in order to correct this problem yet.
 
Manufacturer Narrative
Results of investigation: the devices, intended for use in treatment, was not returned for evaluation and the reported event could not be confirmed.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Our clinical/medical team noted: with the requested clinical information, a thorough medical investigation cannot be rendered.Should any additional medical information be provided this complaint will be re-assessed.A device history review, complaint history, instructions for use and risk management could not be performed due to no product and no product information was provided.At this time a root cause could not be determined with the information provided.
 
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Brand Name
HIP-DUMMY IMPLANT
Type of Device
PROSTHSIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, MTAL/POLYACETL
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key9694570
MDR Text Key178596996
Report Number1020279-2020-00512
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 company representative,health
Type of Report Initial,Followup
Report Date 11/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/11/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received11/02/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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