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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER FEMORAL NAIL

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ZIMMER, INC. ZIMMER FEMORAL NAIL Back to Search Results
Model Number 133240
Device Problems Break (1069); Fracture (1260); Device Dislodged or Dislocated (2923)
Patient Problems Pain (1994); Weakness (2145); No Code Available (3191)
Event Date 01/02/2018
Event Type  Injury  
Event Description
Patient had left im rod placed on (b)(6) 2017, began having severe hip pain on (b)(6) 2017 with subsequent fall on (b)(6) 2017. Presented to ortho surgeon on (b)(6) 2018 and x-ray revealed failed hardware. Im rod was broken. Surgical removal and orif of affected side with new hardware.
 
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Brand NameZIMMER
Type of DeviceFEMORAL NAIL
Manufacturer (Section D)
ZIMMER, INC.
warsaw IN
MDR Report Key7385457
MDR Text Key104032952
Report Number7385457
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 03/30/2018,03/22/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/22/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number133240
Device Catalogue Number47-2493-383-11
Device Lot Number2883281
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/30/2018
Distributor Facility Aware Date01/10/2018
Event Location Home
Date Report to Manufacturer03/30/2018
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 03/22/2018 Patient Sequence Number: 1
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