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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 Problems Unspecified Infection (1930); Injury (2348)
Event Date 01/12/2017
Event Type  Injury  
Event Description
It was reported that the patient underwent a 2 stage revision due to infection and metallic shavings.All the components were removed and replaced with an articulating antibiotic spacer.The patient was originally implanted with an s+n cup and liner mixed with a competitors stem and head.Finally on (b)(6) 2018 the patient was fully revised to unknown devices.
 
Manufacturer Narrative
The devices, used in treatment were not returned for evaluation, reporting event could not be confirmed.A clinical evaluation was conducted and confirms it was reported that the patient underwent a 2 stage revision due to infection and metallic shavings.All the components were removed and replaced with an articulating antibiotic spacer.(b)(6) 2018 the patient was fully revised to unknown devices.It was also reported that the patient was originally implanted with an s+n cup and liner mixed with a competitors stem and head.However, to date no medical records have been received.Without any supporting medical documentation, the reported event cannot be assessed, and a thorough medical assessment cannot be performed.In the event of medical/clinical records being received, the clinical task will be re-opened and a thorough assessment will be rendered at that time.Infection, a potential complication associated with any surgery, can occur and possible causes could include but not limited to contamination, patient reaction, and post-operative healing issue.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.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
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 Key9653455
MDR Text Key177169814
Report Number1020279-2020-00429
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 consumer
Type of Report Initial,Followup,Followup
Report Date 04/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/31/2020
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 Received04/20/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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