MAUDE Adverse Event Report: DEPUY FEMORAL ROD

Device Problems Crack (1135); Device Slipped (1584)

Patient Problem Ambulation Difficulties (2544)

Event Date 02/02/2017

Event Type  Injury  

Event Description

The depuy rod initially placed in leg in (b)(6) 2014 cracked.Rod had to be replaced (b)(6) 2017.The tissue in the upper leg was metal stained.The femoral component was loose and came out in the surgeon's hand.The rod was broken on the femoral component and had to be replaced.Patient has lost flexion since the surgery.Since the surgery, patient had 2 additional surgeries due to complications.Patient was either in hospital or inpatient rehab facility for 2 months.Patient is still wearing a brace and using a walker.Doctor was (b)(6) and hospital was (b)(6).

• Brand Name: FEMORAL ROD
• Type of Device: FEMORAL ROD
• Manufacturer (Section D): DEPUY
• MDR Report Key: 6584696
• MDR Text Key: 75857945
• Report Number: MW5069931
• Device Sequence Number: 1
• Product Code: KWA
• 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: 05/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 83 YR