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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FEMUR BONE; PROSTHESIS, HIP, HEMI-FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

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FEMUR BONE; PROSTHESIS, HIP, HEMI-FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED Back to Search Results
Device Problems Break (1069); Detachment of Device or Device Component (2907)
Patient Problems Fall (1848); Pain (1994); Ambulation Difficulties (2544)
Event Date 06/25/2019
Event Type  Injury  
Event Description
"on the second f/u visit to dr "(b)(6)" i was told there was a piece broken "off" the hardware that he said hardware was in place.Recommended i go to (b)(6) for healing process.I have an appt, (b)(6) 2020 with (b)(6) ortho.On (b)(6) 2019 i slipped off a ladder and fell breaking my upper femur at my hip.Was taken to (b)(6) "driver", (b)(6).Dr (b)(6) did surgery and implanted a medallion driver to attach lower leg to my hip.Two or 3 months on 2nd f/u visit, the x-ray showed the device was broken.X-ray attached in the mail.Dr (b)(6) recommended (b)(6) ortho where i was enrolled in a bone healing process.Was told by dr (b)(6) of (b)(6) that it appeared not to have healed any in 2 months, will have a visit on (b)(6) 2020 to "wait" the process.Still using cane to walk, still have pain.Cannot sleep in a bed, daily in recliner.Metal hardware to replace femur bone.(b)(6) was told - (b)(6) ortho.".
 
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Brand Name
FEMUR BONE
Type of Device
PROSTHESIS, HIP, HEMI-FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
MDR Report Key9750873
MDR Text Key181538799
Report NumberMW5093256
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 01/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/24/2020
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age78 YR
Patient Weight82
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