MAUDE Adverse Event Report: BIOMET FEMUR IMPLANT; FEMUR PROSTHESIS

Device Problem Break (1069)

Patient Problems Pain (1994); Disability (2371); Limited Mobility Of The Implanted Joint (2671)

Event Date 10/11/2011

Event Type  Injury  

Event Description

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.

• Brand Name: FEMUR IMPLANT
• Type of Device: FEMUR PROSTHESIS
• Manufacturer (Section D): BIOMET
• MDR Report Key: 4570201
• MDR Text Key: 5554982
• Report Number: MW5041115
• Device Sequence Number: 1
• Product Code: HSA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention; Disability
• Patient Age: 42 YR
• Patient Weight: 91