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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 Date 11/01/2018
Event Type  Injury  
Event Description
It was reported that the patient 2 or 3 months ago experienced pain, xray shows bone connection loose and bone fracture.Pain is 10 out of 10.Is unknown if a revision surgery has been reported and if devices information.
 
Manufacturer Narrative
The associated complaint device was not returned for evaluation.Therefore, a product analysis could not be conducted.After repeated requests, smith and nephew has been unable to obtain device details.As device details were not made available, device history record and complaint history review cannot be completed.Without the return of the actual product involved and no product information available, our investigation of this report is inconclusive.Our clinical analysis noted that no clinical supporting documents were provided to conduct a thorough assessment of the reported issue.Should additional information be received, the complaint will be reopened.Mimb review: assess severity of complaint case to determine if additional action and further inputs are required for inclusion in medical assessment.Determine if a medical assessment would be performed based on a review of the complaint detail and further recommendations from the medical director/designee.Reviewed during mimb.A medical investigation will be performed.Proceed based on information provided/available for the investigation; if no relevant clinical information is provided, recommend closure.Approved by j.Templeton, medical director.A review of relevant clinical/medical information in the reported issue, inclusive of technique and patient information, to include, but not limited to: ¿patient information ¿surgical procedure/post-operative care review ¿device labeling (including technique guides, ifus, etc.) no relevant clinical medical information was provided to conduct a thorough medical assessment.
 
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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 Key8436796
MDR Text Key139336299
Report Number1020279-2019-01125
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 06/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/20/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Date Manufacturer Received06/19/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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