MAUDE Adverse Event Report: ZIMMER FEMORAL STEM; IMPLANT FEMORAL STEM

Device Problems Contamination (1120); Inadequacy of Device Shape and/or Size (1583); Improper or Incorrect Procedure or Method (2017)

Patient Problems Fall (1848); Bone Fracture(s) (1870); Ambulation Difficulties (2544)

Event Date 10/23/2011

Event Type  Other  

Event Description

In (b)(6) 2011, pt fell and broke femur.On (b)(6) 2011, pt had surgery to fix broken femur.Just moments before surgery, pt "begged doctors not to replace her hip, but just repair the broken femur".To no avail, pt had her left hip replaced.Pt states "they didn't measure it right.Her left hip is 1 1/2 inches longer than her right hip "and now walk with a limp".Also, pt states that before hip replacement, she "was very active, in shape and could pass for someone in their 40's.Now i am out of shape, and getting worse".Her "1st post-op visit, the doctor wasn't there.A young girl who just graduated was there".And she stated "look see my badge, i'm a doctor".The doctor then began removing the stitches from the surgical site and which at that time "dropped the steri-strips on the floor and pick them to and put them on the pt, never changing her gloves or obtaining new steri-strips".The pt said she and her daughter "where in complete shock".When the pt got home, she washed her leg thoroughly and luckily never obtained an infection.

• Brand Name: FEMORAL STEM
• Type of Device: IMPLANT FEMORAL STEM
• Manufacturer (Section D): ZIMMER
• MDR Report Key: 3851254
• MDR Text Key: 4621384
• Report Number: MW5036435
• Device Sequence Number: 5
• Product Code: KWY
• 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: 06/02/2014
• 5 Devices were Involved in the Event: 1 2 3 4 5

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Age: 73 YR