MAUDE Adverse Event Report: ZIMMER LONG CMN; CEPHALOMEDULLARY NAIL

Device Problem Bent (1059)

Patient Problem Pain (1994)

Event Date 09/09/2015

Event Type  Injury  

Event Description

The rod inserted into the right femur bent forming the broken bone apart causing pain.Cause unk.

• Brand Name: LONG CMN
• Type of Device: CEPHALOMEDULLARY NAIL
• Manufacturer (Section D): ZIMMER
• MDR Report Key: 5462931
• MDR Text Key: 39238421
• Report Number: MW5060523
• Device Sequence Number: 1
• Product Code: HSB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Weight: 82