MAUDE Adverse Event Report: ZIMMER ZIMMER; ZIMMER FEMORAL HEAD

Device Problem Device Slipped (1584)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/09/2016

Event Type  Injury  

Event Description

There was an intentionally retained foreign body a zimmer femoral head trial.Several unsuccessful attempts were made to retrieve it, but unfortunately the trial kept slipping deeper into the body.It was decided it was more of a risk to continue attempting to retrieve it.

• Brand Name: ZIMMER
• Type of Device: ZIMMER FEMORAL HEAD
• Manufacturer (Section D): ZIMMER
• MDR Report Key: 5900684
• MDR Text Key: 52955825
• Report Number: MW5064301
• Device Sequence Number: 1
• Product Code: KWL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 68 YR
• Patient Weight: 80