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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FEMORAL IMPLANT IMPACTOR; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
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SMITH & NEPHEW, INC. FEMORAL IMPLANT IMPACTOR; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL Back to Search Results
Catalog Number 71440005
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/07/2018
Event Type  malfunction  
Event Description
It was reported that black plastic broke.No delay.Backup available.
 
Manufacturer Narrative
The associated complaint device was returned and evaluated.A visual inspection of the returned femoral implant indicated that the bumper fractured in two areas near the attachment screws.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part revealed no prior complaints for the listed batch.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.Should additional information be received, the complaint will be reopened.We consider this investigation closed.
 
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Brand Name
FEMORAL IMPLANT IMPACTOR
Type of Device
PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key8200956
MDR Text Key131586561
Report Number1020279-2018-02926
Device Sequence Number1
Product Code JDG
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 company representative,health
Type of Report Initial,Followup
Report Date 01/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/27/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number71440005
Device Lot Number15AM13731
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/14/2018
Date Manufacturer Received12/07/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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