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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY FEM IMPL IMPACTOR; PROSTH, KNEE, PATE/FEMOROTIBIAL, SEMI-CONST, UNCEM, PORO, COAT, POLY/METAL/POLY
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SMITH & NEPHEW, INC. JOURNEY FEM IMPL IMPACTOR; PROSTH, KNEE, PATE/FEMOROTIBIAL, SEMI-CONST, UNCEM, PORO, COAT, POLY/METAL/POLY Back to Search Results
Catalog Number 74012831
Device Problem Material Separation (1562)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/17/2019
Event Type  malfunction  
Event Description
It was reported that during surgery, metal end of the device fell off during case.A backup device was available, no delay and no injury.No debris left in patient.
 
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
JOURNEY FEM IMPL IMPACTOR
Type of Device
PROSTH, KNEE, PATE/FEMOROTIBIAL, SEMI-CONST, UNCEM, PORO, COAT, POLY/METAL/POLY
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key8681410
MDR Text Key147454170
Report Number1020279-2019-02235
Device Sequence Number1
Product Code MBH
UDI-Device Identifier03596010556905
UDI-Public03596010556905
Combination Product (y/n)N
PMA/PMN Number
K121393
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 10/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/09/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number74012831
Device Lot Number06JM15789
Date Manufacturer Received05/17/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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