FEMUR IMPLANT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-02-23 for FEMUR IMPLANT manufactured by Biomet.

Event Text Entries

[5554982] In (b)(6) 2011 my biomet femur implant broke into two segments while i was walking from my car to the entrance of my office building at the (b)(6). The sudden snap of the prosthesis made me think i was hit by a car. Both segments of the biomet prosthesis were pressing up through my skin and i had to force the implant back down into position before it ruptured the skin. I had to call an ambulance, as i was alone, and eventually was taken to (b)(6) hospital in (b)(6). I was in excruciating pain and after several hours was injected with morphine. Biomet was contacted by the hospital but they would not fabricate prosthesis until i would sign a release. The alternative was to undergo a more risky surgery by turning to a different manufacturer and removing an existing knee replacement to accommodate the new prosthesis. I am a cancer survivor and the thought was that a larger surgery would increase my chance of infection. After several days of weighing the risk along with having a pregnant wife i decided to sign an additional ten days in a hospital bed with the broken prosthesis in my leg while biomet fabricated a new component. Biomet changed the original design of the prosthesis at the request of my doctor and i underwent surgery. I remained in the hospital for one week had an incision from my knee to my upper thigh and began rehabilitation. I have lost a large range of motion and can no longer sit in the back of a car, walk steps normally or ride a bicycle, all functions i could perform previously. I have the actual prosthesis and it is clear there was a defect. The implant was under three years old and i never had any trauma to it nor did i run or walk extensively.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5041115
MDR Report Key4570201
Date Received2015-02-23
Date of Report2015-02-23
Date of Event2011-10-11
Date Added to Maude2015-03-06
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationPATIENT
Health Professional0
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameFEMUR IMPLANT
Generic NameFEMUR PROSTHESIS
Product CodeHSA
Date Received2015-02-23
Device Sequence No1
Device Event Key0
ManufacturerBIOMET


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Other; 3. Required No Informationntervention; 4. Deathisabilit 2015-02-23

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