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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FEMORAL IMPLANT IMPACTOR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
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SMITH & NEPHEW, INC. FEMORAL IMPLANT IMPACTOR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED Back to Search Results
Catalog Number 71440005
Device Problem Material Integrity Problem (2978)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/12/2019
Event Type  malfunction  
Event Description
It was reported that during surgery the screw was crooked, does not allow to lock properly.More than 30 minutes delay was reported and no backup device was available.
 
Manufacturer Narrative
The associated complaint device was not returned.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.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
FEMORAL IMPLANT IMPACTOR
Type of Device
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key9177315
MDR Text Key161962380
Report Number1020279-2019-03611
Device Sequence Number1
Product Code JDI
UDI-Device Identifier00885556034156
UDI-Public00885556034156
Combination Product (y/n)N
PMA/PMN Number
K123598
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup
Report Date 11/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number71440005
Device Lot Number18JM16170
Initial Date Manufacturer Received 09/13/2019
Initial Date FDA Received10/10/2019
Supplement Dates Manufacturer Received09/13/2019
Supplement Dates FDA Received11/06/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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