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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ADAPTER HALL/JACOBS TO LG AO; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
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SMITH & NEPHEW, INC. ADAPTER HALL/JACOBS TO LG AO; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Catalog Number 71177205
Device Problem Contamination /Decontamination Problem (2895)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/28/2019
Event Type  malfunction  
Manufacturer Narrative
 
Event Description
It was reported that before surgery, there was rust on the inner part of the adapter.Adapter was opened over the tray and the entire tray had to be reprocessed because of the rust.Delay form 30 minutes to 1 hour.No confirmation of backup has been received.No impact or injury to patient reported.
 
Manufacturer Narrative
The associated complaint device was not returned.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
ADAPTER HALL/JACOBS TO LG AO
Type of Device
PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key9114227
MDR Text Key159945840
Report Number1020279-2019-03471
Device Sequence Number1
Product Code HSX
UDI-Device Identifier03596010601681
UDI-Public03596010601681
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 12/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/24/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number71177205
Date Manufacturer Received12/09/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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